|Year : 2023 | Volume
| Issue : 6 | Page : 9-24
|Date of Web Publication||23-Aug-2023|
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
. Abstracts. Int J Diabetes Technol 2023;2, Suppl S2:9-24
| 1. Assessment of Body Composition and Diabetes Risk Score of Women in Kochi, Kerala|| |
Fiza Nawaz1, Manju P. George2
2Department of Clinical Nutrition, VPS Lakeshore Hospital, Kochi, Kerala, India
Background and Objective: Women are an integral part of human society. Paying due attention to the health of girls and women today is an investment. It has been seen that the greatest burden of death and disability among women is attributable to non-communicable diseases (NCDs), most notably cardiovascular diseases, cancers, respiratory diseases, diabetes, dementia, depression, and musculoskeletal disorders. Unhealthy body composition is a major factor contributing to the development of many such lifestyle diseases. Diabetes can especially adversely affect the quality of life in women. Diabetes can also increase the risk of heart disease (the most common diabetes complication) by about four times in women. The Objective of the study were to analyze the body mass index (BMI), body fat, muscle mass, visceral fat, subcutaneous fat, body age, and Diabetes risk score of 50 middle-aged women. The study also aimed to deliver awareness on the importance of health and wellness in women and to assess the correlation between age and body fat, muscle mass along with the correlation between diabetes risk score and age.
Methodology: 50 middle-aged working women were analyzed with 7 parameters using the bioelectrical impedance method with the input of height, weight, age, and gender. The parameters were:
- Body Mass Index
- Body fat
- Skeletal Muscle mass
- Visceral fat
- Body age
- Resting Metabolism
- Waist circumference
In addition to this, the diabetes risk score was also calculated using information on physical activity, family history of diabetes, etc. from the participants.
Results and Conclusion: It was observed that waist circumference and body fat were elevated in 20-25% of the women. Approximately 50% of the women fell into the obese category. The majority of them (62%) had a low skeletal muscle percentage. 72% of the women had a high diabetes risk score [Figure 1.1]. Older adults were at a higher risk of diabetes than others. This may be due to the higher fat accumulation and sedentary lifestyle. It was noted that the older participants had the lowest skeletal muscle mass and higher body fat compared to the young and middle-aged. This can be attributed to the progressive loss of muscle mass and physical function, collectively known as sarcopenia, which occurs in older adults
Keywords: Body composition, diabetes risk score, skeletal muscle
| 2. Scope of Artificial Intelligence Integrated Cloud-Based Diet Consultation For Diabetes Risk Score Screening and Hepatic Steatosis|| |
Manju P. George1, C. A. Kalpana2
1Department of Clinical Nutrition, VPS Lakeshore Hospital, Kochi, Kerala, India
2Department of Food Science and Nutrition, Avinashilingam Institute for Home Science and Higher Education for Women, Coimbatore, Tamil Nadu, India
Background and Objective: Diabetes risk score screening was conducted with digital support through a cloud-based mobile application integrated with artificial intelligence (AI) developed to provide authenticated medical nutrition therapy. The study aimed to assess the risk for diabetes mellitus using the Indian diabetes risk score (IDRS) through a cloud-based, AI-integrated digital health application along with the effect of online diet modification on nutrient intake, body weight, and hepatic steatosis of proposed liver donors.
Methodology: IDRS was incorporated into the developed AI integrated application for identifying diabetes risk scores. Data were collected from 100 participants without diabetes between 16-88 years using an online questionnaire. Additionally, the effect of very low carbohydrate and low carbohydrate diets on weight loss and hepatic steatosis was analyzed as retrospective data. Statistical analysis included percentage analysis, standard deviation, paired samples test (t-value), and level of significance (p-value).
Results: The study revealed that individuals with one parent with diabetes were more prevalent (54.8%) compared to those with no family history of diabetes (18.6%) or with both parents having diabetes (26.6%). Among the participants, 54% were male, and 46% were female. 36.9% from each category were found to be at high risk for developing diabetes. The analysis showed that 73.8% were at high risk, 19.1% at moderate risk, and 7.10% in the low-risk category. It was observed that the average plasma glucose of the high-risk individuals was higher (38%) than that of the moderate (33%) and low-risk (29%) groups. Participants aged between 51 and 60 years were found to be more prone to developing type 2 diabetes. The study also found significant reductions in body weight (p < 0.05), nutrient consumption, and hepatic steatosis (p < 0.05) in the 'very low carbohydrate diet' and 'low carbohydrate diet' groups. This suggests that these dietary interventions have a positive impact on weight loss and hepatic steatosis in the study participants.
Conclusion: The integration of AI into mobile applications enables Chabot facilities, which can act as a follow-up or reminder tool for individuals at higher risk of diabetes, providing personalized assistance in nutrition follow-up. The online support provided to reduce hepatic steatosis and achieve body weight reduction was found to be effective with proper management, supervision, dietary intervention, and physical activity as advised.
Keywords: Indian diabetes risk score, online-nutrition, low carbohydrate diet
| 3. Clinical Significance Of Circulating Secreted Frizzled-Related Protein 5 (Sfrp5) and Wingless-Type Mmtv Integration Site Family Member 5A (Wnt5a) Levels in People With Prediabtes in a Tertiary Care Centre|| |
Department of Physiology, King George's Medical University, Lucknow, Uttar Pradesh, India
Background and Objective: The aim of this study was to assess the effect of the critical balance between plasma secreted frizzled-related protein 5 (Sfrp5) and wingless-type mmtv integration site family member 5a (Wnt5a) levels, and to investigate the correlation of individual plasma Sfrp5 and Wnt5a levels with the risk factors of prediabetes.
Methodology: Patients registered in the out-patient department were enrolled in this study based on the inclusion and exclusion criteria. The study included 50 people diagnosed with prediabetes and 50 people without prediabetes or diabetes. The inclusion criteria were people aged between 18-70 years with blood pressure higher than 140/90 mmHg. Anthropometric measurements such as blood pressure (BP), body mass index (BMI), waist circumference (WC), and biochemical parameters including fasting plasma glucose (FPG) and lipid profile were measured for each enrolled person. The lipid profile was assessed using a SELECTRA autoanalyser and relevant kits, while blood glucose levels were estimated by the GOD-POD method.
Results: The study found that serum Sfrp5 levels were significantly lower in people with prediabetes compared to control individuals. However, Wnt5a levels were non-significant in both cases and controls.
Conclusion: Based on the present results, it can be concluded that the downregulation of Sfrp5 might play a potential role in the pathogenesis of prediabetes.
Keywords: Downregulation, SFRP-5, WNT-5a
| 4. Real-World Performance of the Minimed 780 G, Advanced Hybrid Closed-Loop System in Kerala|| |
Shahana Yasmin, Jothydev Kesavadev, Arun Shankar, Gopika Krishnan, Anjana Basanth, Geethu Sanal, Sunitha Jothydev
Jothydev's Diabetes Research Centre, Diabetes, Thiruvananthapuram, Kerala, India
Background and Objective: The currently available advanced hybrid closed-loop (AHCL) system, the MiniMed 780G, helps deliver basal insulin automatically every 5 minutes. It provides adjustable blood glucose targets of 100, 110, or 120 mg/dL with automatic correction bolus delivery up to every 5 minutes if required. The performance of this system in a real-world setting in Kerala was evaluated.
Methodology: We analyzed data from the AHCL system, which was uploaded to CareLink personal software by individuals who provided consent for data aggregation. The data was collected from September 15, 2022, to February 1, 2023. We determined glycemic outcomes, including mean sensor glucose (SG) levels and the glucose management indicator (GMI). Descriptive analysis was performed using mean and standard deviation for continuous variables and proportion (%) for categorical variables.
Results: During the observation period (4 months: 54-121 days), a total of 20 users uploaded data into CareLink personal software. Out of these, 18 had type 1 diabetes (T1DM). Among the T1DM users, there were 4 females, with an average age of 16.8±7.49 years and an A1C level of 6.34±0.45. The average duration of diabetes among these users was 7±6.78 years. Users achieved a mean GMI of 6.6%±0.26% with an interquartile range (IQR) of 6.2%–6.9%. They also achieved a time in range (TIR) of 85.0%±8.12%, time below range (TBR; 54-70 mg/dL) of 2.0±0.81, time below range* (TBR* < 54 mg/dL) of 0%, time above range (TAR; 180-250 mg/dL) of 11.5%±6.60%, and time above range* (TAR* > 250 mg/dL) of 3.0%±1.41%. The median (IQR) TIR achieved was 84% (80%–91%), and all users achieved a TIR of >70%. The glucose sensor was in use for an average of 88.5%±8.18% of the time, and users were in AHCL for an average of 96%±3.65% of the time.
Conclusion: This is the first time ever a technology has proved to be effective in safely bringing down HbA1c to below 7% in type 1 diabetes. The use of the AHCL system in a real-world setting among people with T1DM yielded robust data on achievable glycemic control, while also maintaining safety from hypoglycemia.
Keywords: 780G, AHCL, diabetes, TIR
| 5. Screening and Recruitment Challenges of Diabetes mHealth Intervention Program in Urban and Rural Population|| |
Dr. Mohan's Diabetes Specialities Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu, India
Background and Objective: Digital studies often encounter challenges in recruiting diverse participants due to limited access to devices and technology. The study aimed to explore diverse recruitment strategies and overcome challenges for a digital intervention project in urban and rural areas of Tamil Nadu, India.
Methodology: The study employed five distinct strategies to maximize participant enrollment and overcome various challenges. The first strategy involved a two-day screening approach, where participants aged 25-60 years from an international Surveillance study conducted in the study site with fasting blood glucose value of <126 mg/dL were invited to the screening camp the following day. However, the recruitment rate was slow due to a lower turnout of potential participants for the next day. To address this issue, the second strategy used a one-day screening method, processing blood samples from surveillance studies using the point of care system. The Indian Diabetes Risk Score was calculated on the spot, allowing same-day participant recruitment. The third strategy was adapted to the pandemic, as surveillance camps were cancelled due to government restrictions. Data from the study were collected retrospectively, and participants were contacted to assess eligibility and collect basic information. Fasting blood glucose samples were obtained through home visits. In the fourth strategy, the study focused on targeted screening in urban residential colonies, obtaining approval from associations, and conducting individual camps to avoid overcrowding and follow safety guidelines. The fifth strategy involved rural targeted screening, leveraging an existing ongoing study, and selecting villages based on response rates, smartphone usage, and network availability.
Results: A total of 5264 participants were screened. 11.5% (n=610) eligible participants were enrolled in the study, while 88.4% (n=4,654) were found not eligible [Table 5.1]. These results highlight the varying success rates of the different screening strategies and the challenges faced in recruiting eligible participants for the mHealth intervention program.
Conclusion: The research team optimized recruitment efforts, adapted to challenging circumstances, and reached a diverse participant pool. The study offers valuable insights for future research in diabetes screening programs in India.
Keywords: Diabetes, Indian diabetes risk score, recruitment strategies
| 6. User Perception and Outcomes With a Patch Insulin Pump|| |
Junaid Naina, Jothydev Kesavadev, Gopika Krishnan, Anjana Basanth, Arun Shankar, Sunitha Jothydev
Jothydev's Diabetes Research Centre, Diabetes, Thiruvananthapuram, Kerala, India
Background and Aim: The Omnipod 5 is a patch insulin pump that utilizes an automated insulin delivery algorithm, along with a continuous glucose monitoring system (Dexcom G6) and mobile application (Omnipod5 app). It allows for automated insulin delivery based on real-time and predicted glucose values, with a customizable target glucose level range of 110-150 mg/dL. However, there is no real-world data from India on this AID since the device is not available. Nonetheless, we present the outcomes and user experience of 3 individuals with T1D living in India, who procure the system from the United States.
Methodology: We analyzed data from the Omnipod5 App and Dexcom Clarity. Glycemic outcomes, including time in range (TIR), time below range (TBR), time above range (TAR) were determined. We also compared various metrics while on AID and when on multiple daily injections. User experience was collected using structured and semi-structured surveys. Qualitative data from the surveys were analyzed thematically to identify themes related to user experience.
Results: The users (n=3; T1DM; all females; age: 7±3.60 years; duration of diabetes:4.6±3.21 years). The percentage of TAR and TBR decreased by 6.3% and 4.3% (P<0.001) respectively. Mean T1R increased from 79.6±5.6% to 88±6.08% (P < 0.001). The mean total daily dose decreased with AID by 9 units/day (p<0.001). HbA1c decreased significantly from 8.2±0.26% when on MDI along with CGM to 6.43±0.32% when on AID. The patch pump system was well-received by the 3 users. They appreciated the lack of calibration with Dexcom G6, the flexibility provided by the absence of tubing and ease of changing the infusion set (less than 5 minutes). The users reported bare minimum manual interventions and negligible hypoglycemic episodes. However, one of the users experienced issues with the pump peeling off and another one found hypoglycemia management to be occasionally challenging.
Conclusion: The use of the Omnipod5 resulted in improved glycemic outcomes and reduced total daily dose for individuals with T1D. The system was well-received by the users, who appreciated the flexibility inherent to the system. Our study supports the potential benefits of the patch pump for individuals with T1D and underscores the importance of making this technology more widely accessible in the Indian market.
Keywords: AID, omnipod, patch insulin pump
| 7. Prevelance of Sarcopenia in People With Diabetes|| |
Jain Yasmine Henry, Johny J. Kannampilly
Dr. Kannampilly's Diabetes Specialty Centre, Kochi, Kerala, India
Background and Objective: Sarcopenia is a progressive generalized skeletal muscle disease characterized by the loss of muscle mass and decreased muscle function, which increases the risk of adverse events [Figure 7.1]. Recent studies have suggested that sarcopenia may be a significant comorbidity of diabetes mellitus (DM). The aim of this study was to analyze and evaluate the prevalence of sarcopenia in people with diabetes in Kerala.
Methodology: A research investigation was conducted at Metanoia New Health Diabetes and Lifestyle Diseases Research Institute, utilizing data obtained from a body composition analyzer (Tanita MC 780MA) device's generated reports. The data from the reports were carefully prepared and categorized into three distinct groups: Normal, Low, and Very Low, along with different age groups of 20-40, 40-60, and 60-90.
Results: Among a sample of 100 patients, 18% of them were classified as having a low muscle mass index, with a notable 5% experiencing a significant decline in muscle mass. Of the patients diagnosed with a low muscle mass index, 8% belonged to the age group of 40-60, 3% were in the 20-40 age range, and the remaining 7% were aged 60-90. In the case of a very low muscle mass index, out of the total 5%, 2% were from the 40-60 age group, while the remaining 3% were in the 60-90 age group.
Conclusion: Based on the study findings, we can conclude that individuals who are most prone to developing sarcopenia tend to belong to the middle-aged population and onwards, thus providing an alternative perspective that sarcopenia is not exclusive to only the elderly population. Also, women are more susceptible to sarcopenia compared to men. Therefore, it is crucial to conduct body composition assessments and take appropriate measures to address the treatment of sarcopenia.
Keywords: Diabetes mellitus, muscle mass index, sarcopenia
| 8. Noninvasive Liver Stiffness Measurement in an Out-Patient Department Using Fibroscan Technology|| |
StarMax Specialty Clinic, Kandivali and Alexis Diabetes Clinic, Malad, Maharashtra, India
Background and Objective: Non-Alcoholic Fatty Liver Disease (NAFLD) is a term that denotes excessive fat accumulation in liver cells in people who consume little to no alcohol. This condition gradually progresses to a more severe form characterized by liver inflammation called Non-Alcoholic Steatohepatitis (NASH). NASH can further worsen, leading to advanced scarring within the liver and eventually liver failure known as Liver Cirrhosis. NAFLD is one of the leading causes of Cirrhosis and Hepatocellular Carcinoma, and its progression is accelerated in the presence of diabetes, obesity, and/or metabolic syndrome. While death in people with NAFLD often occurs due to cardiovascular disease or extra-hepatic malignancy, liver fibrosis serves as a key prognostic marker for liver-specific outcomes and overall mortality. According to 2022 statistics, almost half of the patients living with diabetes in India also have NAFLD. Therefore, early detection and adequate treatment of NAFLD are essential. Aspartate transaminase/platelet ratio index (APRI Score) and fibroscan test are the recommended non-invasive tests for cirrhosis by the Asian-Pacific Association for the Study of the Liver (APASL). NAFLD fibrosis score (NFS) and FIB-4 Score are other scores that are gaining momentum in assessing the liver disease burden.
Methodology: At our outpatient department, we conducted a screening camp to detect NAFLD in people with diabetes, obesity, and/or metabolic syndrome. Liver stiffness measurement (LSM score) was performed using vibration-controlled transient elastography (VCTE), a standard method for non-invasive assessment of liver stiffness. The fibroscan device used in the process also captured the controlled attenuation parameter (CAP) score, which is patented to assess liver steatosis.
Results: Out of 10 patients (6 females and 4 males), 70% were detected with fatty liver Grades I to III, and 60% of them required either treatment or referral to a hepatologist to halt the progression to NASH [Figure 8.1]. The study also revealed that there was no age association with either LSM or CAP scores.
Conclusion: The non-invasive technique of fibroscan proved effective in detecting existing fatty liver in people with diabetes who were previously unaware of their condition. This helped initiate their journey towards halting the progression of their liver disease.
Keywords: Diabetes, fibroscan, NAFLD, obesity, technology
| 9. Hypertension and Dysglycemia in Retroviral Patients|| |
Sandhya Gautam, Dinesh Rana
Department of Medicine, LLRM Medical College Hospital, Meerut, Uttar Pradesh, India
Background and Objective: Acquired immune deficiency syndrome caused by HIV has been one of the biggest pandemics and global health challenges. This is a cross-sectional study that aims to study the prevalence of hypertension and dysglycemia in HIV patients on highly active antiretroviral therapy (HAART).
Methodology: A total of 120 HIV patients (confirmed by ELISA) above 18 years of age, attending outpatient, and admitted to indoor wards in a hospital in Meerut, were included in the study. People with known cases of diabetes and hypertension, who are on drugs that impair blood glucose levels and affect blood pressure, were excluded from the study. The parameters used for analysis included the duration of HIV, HAART therapy, fasting blood glucose (FBS), and blood pressure.
Results: FBS was elevated in 24.9% of the population, among which 9% were diagnosed with diabetes, and 15.83% fell under the category of insulin resistance. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were higher in patients on Protease Inhibitor (Pl) containing regimen. The mean FBS was also higher in patients on Pl containing regimen.
Conclusion: The length of time an HIV-infected patient is on the HAART regimen significantly increases the odds of developing hypertension and hyperglycemia. Therefore, there is a need to periodically assess HIV patients for cardiovascular risk factors while they are on the regimen.
Keywords: Dysglycemia, HAART, Insulin resistance, PI regime
| 10. Observational Study on the Prevalence of High Mean Platelet Volume Among People With Type 2 Diabetes and People Without Diabetes|| |
Rare Materials Project, Mysore, Karnataka, India
Background and Objective: The prevalence of high mean platelet volume (MPV) among people with diabetes is linked to poor glycemic control, a longer duration of diabetes, and an increased prevalence of vascular complications. High MPV is directly correlated to the atherosclerotic burden in individuals. The aim of this study is to assess whether the observation of high MPV is true in people with diabetes compared to people without diabetes.
Methodology: The study was conducted among individuals who attended the outpatient department in a government dispensary setting with a laboratory facility. A total of 52 people with type 2 diabetes (Group I) and 52 people without diabetes (Group II) were evaluated with a complete hemogram using a 5-part automated analyzer. Patients who were anemic, on antiplatelet, and diagnosed with coronary artery disease were excluded from this study. Informed consent was obtained from all individuals, and data were collected from the study population from February 2023 to April 2023.
Results: The mean age in Group I is 60 +/- 20 years, and in Group II, it is 51 +/- 20 years. The mean MPV in Group I is 8.72, and in Group II, it is 9.06 [Table 10.1]. The standard deviation in Group I is 0.86, and in Group II, it is 1.48. The t-test for two samples assuming equal variances showed a t-statistic of -1.44, and the p-value is 0.08 (which is not highly significant).
Conclusion: The present study shows that the prevalence of high MPV was almost the same in both groups. People with type 2 diabetes have a lower prevalence of high MPV, which could be due to the concomitant prescription of statins as part of their diabetes treatment compared to non-statin use in people without diabetes. Further studies should be conducted on new people with diabetes who are not on statins, which would help shed light on the risk of atherosclerotic burden linked to MPV in people with diabetes. Additionally, the body mass index (Obesity) of the study individuals should be taken into account while making the observation.
Keywords: Atherosclerosis, diabetes, MPV
| 11. Clinical Characteristics and Precipitating Factors of Diabetic Ketoacidosis in Individuals With Type 1 Diabetes|| |
Aniket V. Inamdar1, Bharat Saboo2
1Samarpan Clinic, Omerg, Maharashtra, India
2Prayas Diabetes Center, Indore, Madhya Pradesh, India
Background: The incidence of type 1 diabetes mellitus (T1DM) is increasing worldwide. Diabetic ketoacidosis (DKA), which is caused by absolute insulin deficiency, is the most serious life-threatening acute complication of T1DM. The incidence of DKA at the time of T1DM diagnosis ranges from 15% to 67% depending on the geographic region. Between 10% and 70% of these diagnosed children present in diabetic ketoacidosis, a metabolic derangement characterized by the triad of hyperglycemia, acidosis, and ketonuria.
Aim: Aim of this study was to know the clinical characteristics and precipitating factors of diabetic ketoacidosis in type 1 diabetes mellitus in Indian children and adolescents.
Materials and Methods: This observational study was conducted in rural hospital in India from January 2020-May 2022.The inclusion criteria comprised of patients of type 1 diabetes or undiagnosed cases (first presentation) presenting with DKA in the emergency department. DKA was defined as a biochemical trial of ketonemia, acidosis, and hyperglycemia. Microsoft Excel was used for statistical analysis.
Results: The clinical presentation of all 67 individuals with DKA was diverse and some individuals had one or more symptoms. The most prominent symptom for each individual was taken into consideration. 46.26% presented with severe vomiting, 32.83% with abdominal pain, 14.92% with fever, and 5.9% presented with polyuria/polydipsia. We found that the most common precipitating factors were infections (76%) and non-compliance to treatment (24%).
Conclusions: Understanding which factors are associated with diabetic ketoacidosis at diagnosis is essential to prevent of delayed diagnosis of this life threating complication of diabetes mellitus. This potentially informs both our understanding of the disease as well as the development of patient and population-based interventions to reduce the proportion of children presenting in diabetic ketoacidosis. Awareness among people with diabetes and physicians regarding symptoms and precipitating factors of diabetic ketoacidosis is necessary, as it may help in early diagnosis and timely treatment.
Keywords: Diabetic ketoacidosis, Type 1 diabetes, Hyperglycemia
| 12. Clinical Utility of Hyperbaric Oxygen Therapy in Diabetic Foot Ulcers/Infections|| |
Greeshma B. Panicker
Department of Hyperbaric Medicine and Diabetic Foot Care, SP Fort Hospital, Thiruvananthapuram, Kerala, India
Background and Objective: The incidence of type 1 diabetes mellitus (T1DM) is increasing worldwide. Diabetic ketoacidosis (DKA), caused by absolute insulin deficiency, is the most serious life-threatening acute complication of T1DM. The incidence of DKA at the time of T1DM diagnosis ranges from 15% to 67% depending on the geographic region. Between 10% and 70% of these diagnosed children present with DKA, a metabolic derangement characterized by the triad of hyperglycemia, acidosis, and ketonuria. The objective of this study was to investigate the clinical characteristics and precipitating factors of diabetic ketoacidosis in type 1 diabetes mellitus in Indian children and adolescents.
Methodology: This observational study was conducted in a rural hospital in India from January 2020 to May 2022. The inclusion criteria comprised patients with T1DM or undiagnosed cases (first presentation) presenting with DKA in the emergency department. DKA was defined as a biochemical trial of ketonemia, acidosis, and hyperglycemia. Microsoft Excel was used for statistical analysis.
Results: The clinical presentation of all 67 individuals with DKA was diverse, and some individuals had one or more symptoms. The most prominent symptom for each individual was taken into consideration. 46.26% presented with severe vomiting, 32.83% with abdominal pain, 14.92% with fever, and 5.9% presented with polyuria/polydipsia. We found that the most common precipitating factors were infections (76%) and non-compliance with treatment (24%).
Conclusions: Understanding which factors are associated with DKA at diagnosis is essential to prevent delayed diagnosis of this life-threatening complication. This potentially informs both our understanding of the disease as well as the development of patient and population-based interventions to reduce the proportion of children presenting with DKA. Awareness among people with diabetes and physicians regarding symptoms and precipitating factors of DKA is necessary, as it may help in early diagnosis and timely treatment.
Keywords: Diabetic ulcers, hyperbaric oxygen therapy, diabetic ketoacidosis
| 13. Serum Gamma Glutamyl Transferase Levels in Metabolic Syndrome|| |
Mintu John1, Sudhindra Rao M2
1Department of General Medicine, Mosc Medical College Hospital, Kochi, Kerala, India
2Department of General Medicine, K S Hegde Medical Academy, Mangalore, Karnataka, India
Background and Objective: Metabolic syndrome is a complex clinical condition represented by a cluster of five interconnected risk factors, including abdominal obesity, insulin resistance, high levels of serum triglycerides, low HDL, and hypertension. The presence of three or more of these factors allows the clinical diagnosis of metabolic syndrome. Serum gamma glutamyl transferase (GGT) has been proposed as a useful predictor biomarker for metabolic syndrome, as its levels were found to correlate with an increased risk of metabolic syndrome. The objective of this study is to compare and correlate serum GGT levels in individuals with and without metabolic syndrome, and to assess the correlation of GGT levels with different components of metabolic syndrome, such as fasting blood glucose (FBG), HbA1c, high density lipoprotein (HDL), low density lipoprotein (LDL), and serum triglyceride levels.
Methodology: This was a prospective cross-sectional study conducted from January 2020 to June 2021. A total of 107 individuals with metabolic syndrome were identified based on the International Diabetes Federation (IDF) criteria, and their serum GGT levels were compared with 107 controls without metabolic syndrome.
Results: The difference in mean values of FBG, PPBS, HbA1c, LDL, HDL, and TG were statistically significant among cases and controls (p < 0.05). By using the receiver operating characteristic curve, GGT levels of more than 39.5 were calculated as the most accurate cut-off point (sensitivity 66.5%, specificity - 68.2%) at which the patient was considered at risk of developing metabolic syndrome.
Conclusions: The results of the hospital-based case-control study suggested that GGT may serve as a marker for identifying metabolic syndrome. GGT correlated with parameters of metabolic syndrome such as FBG, PPBS, HbA1c, HDL, LDL, and TG, especially with fasting blood glucose and hypertriglyceridemia, with which it had the highest correlation.
Keywords: FBS, GGT, metabolic syndrome
| 14. A Study on Paederia foetida linn. An Indian Traditional Medicinal Plant and Its Role in Relation to Type 2 Diabetes|| |
Mouli Das Adhikary1, Anuradha Mukherjee2
1Clinical Dietitian and Diabetes Educator, Sanofi, Jalandhar, Punjab, India
2Department of Dietetics and Nutrition, NSHM College of Management and Technology, MAKAUT University, Kolkata, West Bengal, India
Background and Objective: Paederia foetida Linn., commonly known as Gandhali, is used as a medicine for gout, diarrhea, piles, dysentery, ulcers, and is also well-known for its anti-inflammatory, anti-viral, and anti-cancerous activity. Studies have shown that it is a natural remedy for type 2 diabetes among the aborigines of Sikkim Darjeeling and the Himalayan region, as the leaf extract of Paederia foetida Linn. exhibits remarkable anti-hyperglycemic activity. The objective of this study was to find a suitable pre-treatment method for the removal of foul odor from Paederia foetida Linn. leaves, assess the acceptance of the prepared product, analyze the nutritional constituents of the powdered form, and review observational studies on the anti-diabetic and anti-oxidative effects of methanolic Paederia foetida Linn. leaf extract on experimental diabetes nephropathy in rats.
Methodology: The pretreatment process involved collecting, washing, sun drying, dry roasting, and powderization of the leaves. The product was then subjected to organoleptic study and laboratory testing. Data sources were Sabang, Paschim Medinipur. The nutritional constituents of the prepared powder were assessed, followed by a review of observational studies on the antidiabetic and antioxidant activity of the extract of leaves in rats with induced diabetes.
Results: After suitable sun drying for 6-7 days at a temperature of around 450°C, the leaves were thoroughly dehydrated and ground into powder, resulting in the removal of foul odor. The product was further tested for acceptance through organoleptic study. Laboratory testing revealed high values of dietary fiber (International Diabetes Federation (IDF) – 7.46g/100gm) and micronutrients (potassium content – 844.39mg/100gm, iron content – 4.67mg/100gm, calcium content – 200.40mg/100gm). The review on observational study indicated the presence of flavonoids and essential oil, which benefit gut health and create an anti-hyperglycemic effect in individuals with Type 2 diabetes.
Conclusion: In conclusion, the present study suggests that the prepared product can be used to improve the gut health of Type 2 diabetes patients and help maintain glucose levels due to its inherent anti-hyperglycemic properties.
Keywords: Diabetes, gandhali, Indian plants
| 15. Clinical Characteristics and Hospital Outcomes of Symptomatic and Asymptomatic Hypoglycemia in People With Diabetes|| |
Sivaprakash Varadan, Soumya Gopalan
Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
Background and Objectives: Hypoglycemia is a common, preventable consequence of diabetes management and poses a major obstacle to achieving better glycemic control through anti-diabetic therapy. Severe hypoglycemia is associated with an increased risk of mortality, cognitive impairments, and adverse effects on the quality of life for patients. There is an urgent need to scrutinize the clinical spectrum and burden of hypoglycemia to implement appropriate control measures. The aim of this study is to determine and compare the clinical characteristics and hospital outcomes of symptomatic and asymptomatic hypoglycemia in hospitalized people with diabetes.
Methodology: The study was conducted among hospitalized people with diabetes whose bedside capillary blood glucose (CBG) at any point in time was < 70 mg/dl. After obtaining consent, individuals were enquired about the presence of symptoms of hypoglycemia using a questionnaire. Detailed information about precipitating causes and treatment regimens were obtained using a pro forma. Individuals were followed until the time of discharge to analyze hospital outcomes.
Results: Among 200 people with diabetes experiencing hypoglycemia, 111 (55.5%) patients were asymptomatic, and 89 (45.5%) had symptomatic hypoglycemia. People with asymptomatic hypoglycemia were comparatively younger (56.61±14.69 years vs 60.23±11.74 years, p=0.05), had lower admission glycosylated hemoglobin (7.72±1.82% vs 8.55±2.49%, p=0.007), and had a higher mean blood glucose value during the episode (56.38±9.51 mg/dL vs 44.22±11.21 mg/dL, p<0.0001) compared to people with symptomatic hypoglycemia. There were no significant differences in clinical outcome, the composite of hospital complications (16.2% vs 24.7%, p=0.14), or in-hospital length of stay (median- 8 days vs 8 days) between both groups.
Conclusion: Asymptomatic hypoglycemia was common and present in about half of the admitted people with diabetes. Individuals with asymptomatic hypoglycemia were younger compared to those with symptomatic hypoglycemia. Male predominance was observed in both groups. Antibiotic intake was the most common associated risk factor in both groups. Blood glucose values during hypoglycemic episodes were significantly higher among the asymptomatic group, with people having glucose levels near the threshold. There were no differences in clinical outcomes, the composite of hospital complications, or in-hospital length of stay between people with asymptomatic hypoglycemia compared to those with symptomatic presentation.
Keywords: Coma, diabetes, hypoglycemia, seizures
| 16. Observational Case Control Study on Dietary Intake Pattern and its Relationship With Serum Creatinine for the Risk of People With Diabetes|| |
Arpita Patra1, Mouli Das Adhikary2, Anuradha Mukherjee1
1Department of Dietetics and Nutrition, NSHM College of Management and Technology, MAKAUT University, Kolkata, West Bengal, India
2Clinical Dietitian and Diabetes Educator, Sanofi, Jalandhar, Punjab, India
Background and Objective: Diabetic nephropathy is a condition related to renal disease, characterized by a reduced glomerular filtration rate and elevated serum creatinine levels. Over time, the kidney's filtration rate gradually decreases in individuals with diabetes. Hypertension is also more frequently diagnosed in people with type 2 diabetes mellitus (T2DM) compared to those without diabetes. The aim of this study was to compare the association between elevated serum creatinine levels and dietary intake patterns among people with T2DM and other people without diabetes.
Methodology: Serum creatinine levels were measured in people with T2DM (cases) and people without diabetes (controls). Data was collected using a predesigned pretested questionnaire containing sociodemographic and clinical parameters, as well as a food frequency questionnaire.
Data Sources: IQ City Medical College & Hospital, Durgapur, Paschim Bardhaman.
Study Selection: Observational case-control study reporting the effects of creatinine levels on people with T2DM (cases) and people without diabetes (controls).
Results: There was a significant difference in serum creatinine levels and estimated glomerular filtration rate (eGFR) between the case and control groups. However, there was no statistically significant difference in creatininogenic food intake patterns between the two groups, and there was no significant correlation between specific food intake patterns and elevated serum creatinine levels.
Conclusion: Based on our present study, we conclude that there is no significant relationship between creatininogenic food intake and the onset of T2DM.
Keywords: Diabetes, dietary pattern, serum creatinine
| 17. Survey to Understand Current Practice For Early Dual Combination Therapy in Type 2 Diabetes Mellitus|| |
Ganapathi Bantwal1, Sambit Das2, Neeta Deshpande3, Rahul Iyer4, Amarnath Sugumaran4
1Department of Endocrinology, St. John's Medical College, Bengaluru, Karnataka, India
2Endeavour Clinic, Bhubaneswar, Odisha, India
3Belgaum Diabetes Centre and Weight Watch Centre, Belgaum, Karnataka, India
4Medical Affairs, Cipla Ltd., Mumbai, Maharashtra, India
Background and Objective: Aggressive early management of type 2 diabetes mellitus (T2DM) has demonstrated clinical benefits. However, there is no study that provides the current clinical practice scenario on early T2DM management. This survey was conducted to understand the current practice of early and aggressive T2DM management and its perceived benefits and challenges.
Methodology: A cross-sectional survey of healthcare professionals (HCPs) treating T2DM from various Indian cities/towns was conducted between November 2019 and June 2020. A structured questionnaire was digitally administered to record the responses. Data were analyzed and expressed in descriptive statistics.
Results: A total of 336 HCPs completed the survey, with more than 60% of them being in the 30-50 years age group and having a private consulting practice. Almost 80% of HCPs had a post-graduate degree in medicine (MD). The majority of HCPs (68%) opined that they correlate HbA1c 6.5-7% with the term 'early diabetes'. However, only 15% of HCPs mentioned that their patients get diagnosed at HbA1c 6.5-7%. HbA1c level at diagnosis for the majority (>50%) of HCPs was 7.5-9.0%. At HbA1c <7.5%, lifestyle modifications (LSM) + single drug was the most preferred option (59%), followed by LSM + dual drug combination (29%). Metformin + DPP4 inhibitor combination was the most preferred treatment choice across HbA1c levels (ranging from 34 to 57% of HCPs). More than 70% of HCPs opined that initiating with a single drug fails within 12 months of initiation in the majority of T2DM patients. In the same time frame, 46% of HCPs opined that initial dual drug therapy fails in the majority of patients. Hypoglycemia was the most common (66%) clinical challenge in initiating dual combinations in early diabetes.
Conclusion: Late diabetes diagnosis is commonly observed in clinical practice. In early diabetes, management mostly involves lifestyle modifications and a single drug, despite the knowledge of low glycemic durability observed with this approach. Thus, interventions to overcome the challenges for the use of aggressive management early in T2DM are essential.
Keywords: Combination, dual, early diabetes, DPP4
| 18. A Randomised Controlled Trial to Evaluate Efficacy and Safety of Vildagliptin SR Plus Dapagliflozin in Type 2 Diabetes Mellitus|| |
Animesh Maiti1, Prashant Kumthekar2, Navya K Antony3
1Department of Endocrinology, Medical College and Hospital, Kolkata, West Bengal, India
2Department of Clinical Research, Exemed Pharmaceuticals, Vadodara, Gujarat, India
3Department of Medical Affairs, Cipla India Ltd., Mumbai, Maharashtra, India
Background and Objective: India bears a significant burden of diabetes, including a large number of individuals with uncontrolled diabetes. There is a pressing need for an effective and safe glucose-lowering treatment option. The objective of this study was to evaluate the efficacy and safety of the combination of vildagliptin sustained release (SR) plus dapagliflozin in people with type 2 diabetes mellitus (T2DM) who were inadequately controlled on metformin monotherapy.
Methodology: This was a randomized-controlled phase III trial with three study arms. Arm A received vildagliptin SR 100 mg plus dapagliflozin 5 mg, Arm B received vildagliptin SR 100 mg plus dapagliflozin 10 mg, and Arm C received saxagliptin 5 mg plus dapagliflozin 10 mg. The primary efficacy endpoint was the mean change in glycosylated hemoglobin (HbA1c) from baseline to week 24.
Results: A total of 270 participants were randomized into the three study arms (n=90 in each arm). At week 24, all three arms showed statistically significant reductions in HbA1c from baseline (~9.0%). The reductions were similar between Arm A and C (p=0.9989) as well as between Arm B and C (p=0.7776). The mean reduction in fasting plasma glucose at week 24 from baseline (~175 mg/dL) was 38.52 mg/dL in Arm A, 40.54 mg/dL in Arm B, and 40.42 mg/dL in Arm C. The mean reduction in 2-hour postprandial plasma glucose from baseline (~264 mg/dL) at 24 weeks was 74.48 mg/dL, 75.5 mg/dL, and 76.73 mg/dL in Arms A, B, and C, respectively. At week 24, the proportion of patients achieving HbA1c < 7% was similar in all three arms (48.8% in Arm A, 54.4% in Arm B, and 52.2% in Arm C; p=0.4325). Body weight reduced in all three arms (1.76 kg, 2.19 kg, and 2.08 kg in Arms A, B, and C, respectively) with no significant difference among the arms (p=0.4297). The most frequently observed adverse events in the trial were hypoglycemia (4.81%), nasopharyngitis, and urinary tract infections (2.22% each). No deaths, hospitalizations, or serious adverse events were reported in all three arms.
Conclusion: In individuals with T2DM uncontrolled on metformin, the combination of vildagliptin SR + dapagliflozin demonstrated significant reductions in HbA1c from baseline and also showed non-inferiority to saxagliptin + dapagliflozin. The combination was found to be safe and well-tolerated.
Keywords: Dapagliflozin, diabetes mellitus, HbA1c, vildagliptin
| 19. Impact of Meal Timings and Dietary Modifications on the Glycemic Control For Women With Gestational Diabetes Mellitus In Trivandrum City|| |
N. G. Krishna Priya
Onco Cancer Center, Hyderabad, Telangana, India
Background and Objective: Gestational diabetes mellitus (GDM) is a condition where pregnant women without previously diagnosed diabetes experience high blood glucose levels during their pregnancy. The objective of this study was to investigate the impact of dietary modifications and changes in meal timings on blood glucose levels in women with GDM, as well as to assess the adherence to prescribed diet plans.
Methodology: A random sample of 300 pregnant women with GDM attending the outpatient was selected based on certain inclusion criteria. Baseline information on personal and socioeconomic profiles, along with anthropometric measurements, was assessed in the larger sample. The micro samples received lifestyle modifications and diet counseling. Clinical assessment and biochemical estimations were conducted before and after diet counseling in sub-samples.
Results: The study showed that hormonal changes during pregnancy can impact GDM. Changes in food habits based on hormonal levels positively affected the health status of women with GDM. Those who strictly followed the prescribed diet plan with early breakfast, lunch, and dinner were able to maintain normal blood glucose levels until delivery. Approximately 96% of the respondents adhered to the guidelines of diet intervention by adjusting their meal timings and calorie intake. Only four percent of participants who did not follow the prescribed timings and calorie intake showed a negative impact on their blood glucose levels.
Conclusion: GDM presents an opportunity for preventing diabetes in two generations. Controlling blood glucose levels during pregnancy is vital for both the fetus and mother and can help prevent overweight in the next generation, a root cause of various metabolic disorders. Therefore, the additional focus on meal timings, along with energy restriction, is essential to effectively manage GDM.
Keywords: GDM, glycemic control, meal timings
| 20. Personal Hygiene and SGLT2i|| |
Medical Department of Indian Railways, Lumding Divisional Railway Hospital
Background and Objective: The role of personal hygiene in preventing perineal infection arising from SGLT2i usage is studied to assess the effect of washing the perineal area with water only after every act of micturition in preventing genital infection related to SGLT2i usage.
Methodology: The study involved 30 individuals aged 40-55 years with type 2 diabetes mellitus (T2DM), including both males and females, who were uncontrolled on metformin and glimepiride of varying strength and dosage schedule. They were equally divided into intervention and control groups. Both groups were administered dapagliflozin 10 mg for the first time. The intervention group received education and counseling on maintaining personal hygiene strictly, while the control group did not receive any counseling on personal hygiene. Both groups were followed up weekly for four months to detect any perineal infections following SGLT2i usage.
Results: No perineal infections were noted in the intervention group. However, in the control group, perineal infections were observed in all 15 patients, with most of them being fungal infections. Eleven of them had fungal infections in their genital area, while four had mild urinary tract infections that were successfully treated with oral medication on an outpatient basis [Figure 20.1].
Conclusion: The study concludes that T2DM patients on dapagliflozin (SGLT2i) can prevent perineal infections by maintaining proper personal hygiene. Regular washing of the perineal area with water after micturition can significantly reduce the risk of genital infections associated with SGLT2i usage.
Keywords: Prevention of infection, T2DM, SGLT2i
| 21. Evaluating Dipeptidyl Peptidase 4 Inhibitor Choice in Diabetes Mellitus Among Indian Clinicians|| |
Rahul Iyer1, Faraz Farishta2, Suresh Damodharan3, Akshay Bafna4, Dakshayini Suresh5, Shibani Supe1, Amarnath Sugumaran1
1Medical Affairs, Cipla Ltd., Mumbai, Maharashtra, India
2FS Endocrine and Diabetic Centers, Hyderabad, Telangana, India
3Department of Diabetology, Sri Ramakrishna Hospital, Coimbatore, Tamil Nadu, India
4Department of Cardiology, Government Medical College and CPR Hospital, Kolhapur, Maharashtra, India
5Harvey Specialty Clinics, Coimbatore, Tamil Nadu, India
Background and Objective: In India, there are multiple dipeptidyl peptidase 4 inhibitors (DPP4i) available for the management of type 2 diabetes mellitus (T2DM). However, these DPP4i drugs belong to a heterogenous group with differences among the molecules. This study aims to evaluate the choice of DPP4i among Indian healthcare practitioners (HCPs) when used in the management of T2DM patients with and without comorbidities or complications.
Methodology: A cross-sectional questionnaire-based survey of HCPs was conducted across India from December 2022 to March 2023. The data collected from the survey were analyzed and expressed as descriptive statistics.
Results: A total of 1033 HCPs participated in the survey, with more than two-thirds of them falling in the age range of 31-50 years (71.73%). The majority of HCPs had a postgraduate degree in medicine (MD; 66.6%) and a private consulting practice (74.93%). Approximately half of the HCPs opined that the effectiveness of DPP4i is similar in T2DM patients regardless of age (47.24%) and BMI (46.95%) categories. Among all the available DPP4i in India, sitagliptin was considered to provide greater HbA1c reduction (72.80%), faster reduction in blood glucose (71.25%), and greater improvement in glycemic variability (73.28%). Sitagliptin was the preferred DPP4i choice in T2DM patients, regardless of age (<50 years: 78.03%; ≥50 years: 70.96%), with higher preference in the younger age group. About 75% of HCPs preferred sitagliptin in T2DM patients with comorbidities such as overweight/obesity, hypertension, and dyslipidemia. Similarly, >75% of HCPs preferred sitagliptin as the choice of DPP4i in T2DM patients with atherosclerotic cardiovascular disease and heart failure. Sitagliptin remained the most preferred DPP4i in T2DM patients with chronic kidney disease, with the proportion of HCPs choosing linagliptin increasing as the estimated glomerular filtration rate (eGFR) values decreased. Most HCPs (65.25%) opined that sitagliptin was associated with fewer adverse events in people with T2DM.
Conclusion: The survey results suggest that sitagliptin is the preferred choice of DPP4i among Indian HCPs for the management of T2DM patients, regardless of the presence of comorbidities or complications.
Keywords: DPP4i, HbA1c, survey, T2DM
| 22. Diabetes and Oral Health|| |
Firdous Shaikh1, Noora Pathan2
1Department of Diabetology, Diabetico for Apex Groups of Hospitals
2Aesthetic Dental Consultant and General Dental Surgeon at Happy 32 Dental Clinic, Mumbai, Maharashtra, India
Background and Objective: The relationship between diabetes and oral health is significant, with oral diseases such as dental caries and periodontal disease being highly prevalent in diabetes patients. Moreover, the negative effects of tobacco on oral soft tissue, including pre-malignancy and malignancy, are well-known. These conditions not only have physical consequences but also impact patients psychologically, socially, and economically. This case presentation aims to explore the connection between diabetes and oral health, highlighting the importance of multidisciplinary collaboration and comprehensive care.
Methodology: Mrs. X, a 56-year-old female with a 6-year history of diabetes, presented at the dental clinic with complaints of exaggerated dentinal hypersensitivity. She was on a combination of oral hypoglycemic agents, metformin 500mg + glimepiride 2mg twice a day, and was a chronic tobacco chewer. Mrs. X reported chronic hypersensitivity, dry mouth, worn-off teeth, frequent gingival bleeding on brushing, and stained teeth [Figure 22.1]. Her HbA1c was 8.7%, Fasting Blood Glucose (FBG) 146 mg/dl, Post Prandial Blood Glucose (PPBG) 186 mg/dl, and High Sensitive C-reactive Protein (HsCrp) 5.35 mg/L, indicating sub-optimal blood glucose control and inflammation. Her renal and liver function tests showed no abnormalities.
Results: The patient was provided with intensive oral hygiene instructions, including regular brushing and flossing techniques. Anti-tobacco counselling sessions were conducted to help her taper off tobacco. Scaling and root planning were performed to control periodontal inflammation. Endodontic and restorative procedures were planned to address dental caries, hypersensitivity, and severe attrition. Her diabetes medications were revised to metformin 1000 mg + sitagliptin 50 mg twice a day. After three weeks, significant improvements were observed, with her FBG at 102 mg/dl and PPBG at 130 mg/dl, and her periodontal inflammation reduced.
Conclusion: Diabetes creates an environment conducive to the growth of pathogenic bacteria, while inflammatory mediators associated with periodontal disease can worsen insulin resistance and glycemic control, establishing a bidirectional relationship between diabetes and oral health. Regular follow-up with a diabetologist and routine dental examinations can lead to improved patient outcomes and enhance overall quality of life.
Keywords: Diabetes, oral infection, tobacco
| 23. Greater Time Spent in Glycemic Control With Oral Semaglutide Versus Oral Comparators|| |
R. Visakh1, Filip K. Knop2, Bertrand Cariou3, Johanna Eliasson4, Guillaume Frappin4, Margit S. Kaltoft4, Eduard Montanya5, Julio Rosenstock6
1Regional Medical Advisor, Novo Nordisk, Kerala, India
2Steno Diabetes Center Copenhagen, Gentofte, Denmark
3Nantes Université, CHU Nantes, CNRS, Inserm, l'institut du Thorax, Nantes, France
4Novo Nordisk A/S, Søborg, Denmark
5Hospital Universitari Bellvitge - IDIBELL, CIBERDEM, and University of Barcelona, Barcelona, Spain
6Dallas Diabetes Research Center at Medical City, Dallas, TX, USA
Background and Objective: The objective of this exploratory analysis was to investigate the duration of time patients spent with HbA1c levels below 7.0% and their likelihood of maintaining this glycemic target in PIONEER efficacy trials lasting for at least 52 weeks.
Methodology: Participants with uncontrolled type 2 diabetes mellitus (T2DM) in the PIONEER 2, 3, 4, and 7 trials were randomly assigned to receive either oral semaglutide or active comparators (empagliflozin 25 mg, sitagliptin 100 mg, liraglutide 1.8 mg once daily). The dosage of oral semaglutide was escalated, starting at 3 mg once daily and increasing to 7 mg after 4 weeks, then to 14 mg after 8 weeks in most trials, except PIONEER 7, which used a flexible dose adjustment based on HbA1c and gastrointestinal tolerability. Empagliflozin was initiated at 10 mg and escalated to 25 mg after 8 weeks. Sitagliptin was initiated at 100 mg and not escalated. Liraglutide was initiated at 0.6 mg and escalated to 1.2 mg and then 1.8 mg after 1 and 2 weeks, respectively. Data analysis was performed using a logistic regression model.
Results: The mean baseline HbA1c levels ranged from 8.0 to 8.3%. Patients treated with oral semaglutide spent a greater median duration of time with HbA1c levels below 7.0% (26.3–33.7 weeks) compared to those on oral comparators (0–10.9 weeks) [Table 23.1]. The mean duration of time spent with HbA1c levels below 7.0% was also higher for oral semaglutide compared to oral comparators [Table 23.1]. The mean and median duration of time spent in glycemic control with oral semaglutide was similar to that seen with liraglutide. A higher proportion of patients achieved HbA1c levels below 7.0% for at least 38 weeks with oral semaglutide compared to empagliflozin (46% vs. 28%, respectively) and sitagliptin (PIONEER 3: 45% vs. 28%, respectively; PIONEER 7: 27% vs. 14%, respectively), but not liraglutide (46% vs. 48%, respectively). The odds of patients achieving HbA1c levels below 7.0% at both week 26 and 52 were significantly greater with oral semaglutide compared to comparators [Table 23.1].
Conclusion: In PIONEER trials lasting for at least 52 weeks, oral semaglutide demonstrated superior glycemic control, with patients spending more time at the target HbA1c level and a greater likelihood of maintaining glycemic control compared to oral comparators. Despite a longer dose-escalation period with oral semaglutide, individuals receiving this treatment spent a similar time in glycemic control compared to those receiving liraglutide.
Keywords: Diabetes, incretin therapies, oral semaglutide
| 24. Observational Study on the Prevalence of Hepatic Fibrosis Among People With Diabetes and People Without Diabetes|| |
Rare Materials Project, Mysore, Karnataka, India
Background and Objective: The incidence of fatty liver is increasing among people with type 2 diabetes mellitus (T2DM), eventually leading to fibrosis and cirrhosis. The aim of this study is to assess whether people with T2DM have an increased prevalence of liver fibrosis compared to people without diabetes.
Methodology: The study was conducted among individuals who attended the outpatient department in a government dispensary setting with a laboratory facility. A total of 52 people with T2DM (Group I) and 52 people without T2DM (Group II) were evaluated with a complete hemogram using a 5-part automated analyzer and liver function test using a semi-automatic biochemistry analyzer. The age of the individuals was noted while obtaining informed consent. Data was collected from the study population from February 2023 to April 2023. The fibrosis score was calculated using the FIB-4 calculator.
Results: The mean age in Group I is 60 +/- 20 years, and in Group II, it is 51 +/- 20 years. The mean FIB-4 (fibrosis index based on four factors) score in Group I is 1.42, and in Group II, it is 1.18 [Table 24.1]. The standard deviation in Group I is 0.61, and in Group II, it is 0.73. The t-Test for two samples assuming equal variances showed a t-statistic of 1.78, and the p-value is 0.04 (which is significant).
Conclusion: Based on the above details, the prevalence of liver fibrosis is confirmed to be higher among people with type 2 diabetes. Plans should be made to include the prevention of liver fibrosis in type 2 diabetes management guidelines, similar to the approach taken for hypertension and dyslipidemia treatments.
Keywords: Diabetes, FIB-4, fibrosis
| 25. Current Practice and Perceptions on the Screening, Diagnosis and Use of Mineralocorticoid Receptor Antagonist in Heart Failure|| |
Subhash Sonawala1, G. S. Kohli2, S. Saikiran3, Srinivas Kulkarni4, Febin Francis5, Nitin Zalte5, Amarnath Sugumaran5
1Dr. Subhash Sonawala Clinic, Mumbai, Maharashtra, India
2Joy Nursing Home, New Delhi, India
3Department of Diabetology, People Tree Hospitals, Bengaluru, Karnataka, India
4Sri Clinics, Hyderabad, Telangana, India
5Medical Affairs, Cipla Ltd., Mumbai, Maharashtra, India
Background and Objective: Heart failure (HF) is a significant health burden worldwide, affecting millions of people in India. This study aimed to assess the practices and perceptions of Indian physicians regarding the screening, diagnosis, and management of HF in the country.
Methodology: A digital questionnaire study was conducted among 528 physicians across India between November 2022 and April 2023.
Results: According to 44.5% of physicians, 10-24 HF patients seek consultation in a week, indicating the prevalence of HF cases in India. The average age of patients presenting with HF was reported to be 40-60 years by 62% of physicians. Among HF patients, 75% had HF with reduced ejection fraction (HFrEF), while 25% had HF with preserved ejection fraction (HFpEF). Hypertension was observed in 50% of HFrEF patients and 75% of HFpEF patients, and diabetes was the most common comorbidity in 50% of patients. Regarding guideline-directed medical therapy (GDMT) for HF, 60% of physicians preferred parallel initiation of GDMT drugs, while 40% preferred sequential addition of GDMT drugs. The mineralocorticoid receptor antagonist (MRA) was the first-line treatment option for 48% of physicians, followed by angiotensin receptor II blocker - neprilysin inhibitor (23.8%), beta-blockers (22.1%), and sodium-glucose cotransporter-2 inhibitors (5.8%). The majority of physicians (88.6%) preferred MRA for HF treatment, while 11.3% did not prefer MRA therapy. Among MRAs, 54.7% of physicians preferred spironolactone, and 45.3% preferred Eplerenone. Loop diuretics were commonly prescribed alongside MRA therapy by 92% of physicians. For MRA therapy initiation, 77.8% of physicians preferred a 25 mg dose, and 22% preferred 50 mg. Improvement in New York Heart Association class (41.1%) was reported as the most significant outcome with MRA therapy. Additionally, 37.3% of physicians reported mortality benefits with MRA in 50% of HF patients. The incidence of hyperkalemia was observed in <25% of HF patients on MRA, according to 80.9% of physicians. However, 55.3% of physicians agreed that MRAs are under-dosed, and 49.1% felt that MRAs are underutilized in the management of HF in India.
Conclusion: The study revealed the usage pattern of MRA among GDMT for HF treatment in India. While MRA was considered a first-line drug by the majority of physicians, it was also evident that MRAs are underutilized and under-dosed in Indian clinical practice. Addressing these gaps may lead to better management and outcomes for HF patients in India.
Keywords: GDMT, heart failure, MRA, physicians
| 26. Adoption of Continuous Glucose Monitoring For Diabetes Management: An Outpatient Department Perspective|| |
Diabetologist and Director, Diabetes Care Centre, Mumbai, Maharashtra, India
Background and Objective: Technology in diabetes is generating considerable interest in various scientific platforms. Among the available options, Continuous Glucose Monitoring (CGM) is gaining popularity but hasn't been widely adopted, mainly due to cost constraints. Evaluating the merits and demerits of using CGM in diabetes management is essential, considering its potential benefits beyond glycemic reduction. The objective of this study was to explore the factors and outcomes associated with CGM usage apart from glycemic improvement.
Methodology: We conducted this study at our outpatient department to examine the factors and outcomes related to CGM usage, considering factors beyond glycemic control.
Results: Our analysis revealed a male predominance in decision-making regarding medical expenses for the family. Initially, there was some resistance, but patients eventually embraced the technology and reported satisfaction with the enabling capacity of CGM. Previous studies' evidence reiterated that while HbA1c remains crucial for diagnosing diabetes, it is insufficient for effective diabetes management as it does not provide a comprehensive view of the patient's glycemic profile.
Conclusion: The study strongly supports the adoption of CGM, indicating that clinical practices in diabetes can be positively transformed by using this tool. It highlights the need to evaluate influencing factors in a larger sample size, especially in countries like India, where medical expenses are borne by patients themselves. This would allow us to extend the benefits of diabetes management advances to a broader population across various economic groups in India.
Keywords: CGM, diabetes, evidence, HbA1c, outcomes
| 27. The Rise and Fall of Piperacillin – Tazobactam in Diabetic Foot Infections in a Semi Urban Town in Kerala|| |
Rohit Jacob, Navjith Erezhath Sunil
Department of Medicine, CRAFT and AR Superspeciality Hospital Kodungallur, Thrissur, Kerala, India
Background and Objective: With the increasing incidence of infectious diseases in India and the country's status as the global diabetes capital, the treatment of diabetic foot infections has become challenging due to rising antimicrobial resistance. One commonly used antibiotic in in-patient scenarios is Piperacillin–Tazobactam, which has significantly contributed to the development of resistant bacteria. This article aims to highlight the trends in the use of Piperacillin–Tazobactam in Diabetic foot infections in a tertiary care hospital in Kodungallur, Kerala, and its impact on antimicrobial resistance. The study aims to assess the prevalence of diabetic foot infections and the use of Piperacillin–Tazobactam in a tertiary care hospital in Kodungallur, Kerala. It also evaluates Culture & Sensitivity reports and compares the antibiotic's sensitivity in treating Diabetic foot infections.
Methodology: This retrospective, observational study was conducted in a tertiary care hospital in Kodungallur, Kerala, over a period of 6 months. The study included 300 individuals admitted to the department of Medicine, Surgery & Orthopedics. Data was collected from medical records, including parameters such as age, gender, diagnosis, antibiotics used, department of admission, and culture & sensitivity reports.
Results: Out of 300 people admitted with diabetic foot infections, 185 (61.6%) individuals were started on Piperacillin–Tazobactam as the initial antibiotic of choice upon admission. The next most common antibiotics administered were Metronidazole (26%) and Clindamycin (18.6%), followed by other antibiotics. Among the 197 culture positive reports, 136 (69.03%) were resistant to Piperacillin–Tazobactam. The highest resistance was observed with the growth of Streptococcus pneumoniae.
Conclusion: To combat antimicrobial resistance, certain steps at the grassroot level are essential. Establishing an infectious disease committee for approval before starting high-grade antibiotics, sending culture & sensitivity samples for all diabetic foot infection cases upon admission, and de-escalating antibiotics after 48 hours of obtaining culture reports are crucial measures to preserve the efficacy of potent antibiotics in the battle against bacteria.
Keywords: Antibiotic, culture, diabetes, infection, resistance
| 28. Diabetes With Vocal Cord Palsy – Rare or Forgotten Association|| |
MGM Speciality Hospital, Srikalahasti, Andhra Pradesh, India
Introduction and Objective: Diabetes mellitus affects various systems in the body, including the neurological, vascular, muscular, and gastro-oesophageal systems. Studies have indicated a higher prevalence of vocal fold paralysis among individuals with diabetes mellitus compared to those without the condition. The objective of this case report is to describe the presentation, management, and outcome of this unique case.
Case Presentation: We present the case of a 57-year-old individual with diabetes, who has been on regular medications for 30 years. Both of the patient's parents have also been diagnosed with diabetes. The patient is a nonsmoker, nonalcoholic, and normotensive. He was treated with a combination of sitagliptin and metformin outside our clinic. He initially presented with recurrent sore throat and hoarseness of voice, for which he received antibiotics. However, the symptoms persisted, and he returned after 15 days with hoarseness again. Upon reviewing his medication history, we advised him to discontinue sitagliptin due to the recurrence of lower respiratory tract infections (LRTI).
Management and Outcome: His fasting blood sugar (FBS) level was 180 mg/dl, postprandial blood sugar (PPBS) level was 282 mg/dl, and HbA1c level was 8.4 mg/dl. Other relevant parameters were total cholesterol (160 mg/dl), estimated glomerular filtration rate (eGFR - 90 mg/dl), and urine proteins (negative). Ophthalmoscopic examination showed no retinopathy. Monofilament test (10 gm) indicated loss of protective sensation (LOPS+), and Biothesiometry revealed moderate Diabetic peripheral Neuropathy. There were no signs of resting tachycardia or orthostatic hypotension. Upper gastrointestinal (UGI) endoscopy showed normal results. An Ear, Nose, and Throat (ENT) surgeon was consulted, and the patient underwent Video laryngoscopy, which revealed unilateral vocal cord palsy/right hemilarynx paralysis with Lingual tonsillar hypertrophy [Figure 28.1]. High-resolution computed tomography (HRCT) of the thorax showed normal findings. An MRI of the brain was conducted with consultation from a Neurologist, which revealed idiopathic vocal cord palsy. The patient showed improvement with tight metabolic control.
Discussion: Hyperglycemia and imbalances in fluid and electrolytes in diabetes mellitus can indirectly affect the voice. Xerostomia, which is common in diabetes, can lead to impaired hydration of the laryngeal mucosa, complicating phonation [Figure 28.2]. Diabetic neuropathy can also disrupt the function of laryngeal muscles involved in voice formation. Studies have shown that individuals with neuropathy are more likely to report vocal straining, aphonia, and hoarseness compared to those without neuropathy. Another study by HAMDAN et al. found that laryngeal sensory neuropathy is more prevalent in people with diabetes mellitus than in control groups.
Keywords: Vocal cord palsy, FBS,PPBS, Xerostomia
| 29. Correlation Between Hba1C and Time in Range in People With Type 2 Diabetes With Normal HbA1c, Attending a Tertiary Care Medical College Hospital in South India|| |
Edwin J. George, Steffin Mathai Kaattoor, Navein Thomas John, Thomas Joseph, Cyrin Annie Cyriac, Maridas Tom
Department of Medicine, Amala Institute of Medical Sciences, Thrissur, Kerala, India
Background and Objective: Diabetes mellitus has a high prevalence in our country and is known to cause significant morbidity and mortality. In 2010, the role of the A1C test was expanded when the American Diabetes Association (ADA) included HbA1c as a diagnostic criterion for diabetes. However, a normal HbA1c level does not necessarily indicate euglycemia over the past three months, as intra-day and inter-day glycemic variability can significantly influence HbA1c levels. To address this issue, a new parameter called “Time in Range (TIR)” has emerged. TIR represents the duration spent within the target blood glucose range of 70 to 180 mg/dL for most individuals. Achieving a TIR of at least 70%, approximately 17 out of 24 hours each day, is the goal for all people with diabetes. Continuous Glucose Monitoring Systems (CGMS) are commonly used to assess TIR and provide valuable insights into glycemic variability. The objective of this study is to explore the correlation between HbA1c and TIR in diabetes patients with normal HbA1c levels.
Methodology: A total of 99 individuals aged between 18 to 60 years, receiving both outpatient (OP) and inpatient (IP) care, were included in the study after excluding patients with conditions that could artificially elevate or lower HbA1c levels. All participants wore an Abbott Freestyle Libre Pro CGMS device on their left arm for two weeks. After this monitoring period, Ambulatory Glucose Profiles (AGP) were generated, providing a visual representation of the time spent above and below the target range [Figure 29.1].
Results: The study revealed that only 62 individuals achieved a TIR greater than 70%, with only 9 out of the total population reaching a TIR exceeding 95%. Participants on insulin therapy showed a higher incidence of glycemic variability, and approximately 28% of the population experienced nocturnal hypoglycemia.
Conclusion: The findings of this study highlight a substantial prevalence of glycemic variability, including asymptomatic hypoglycemia, even among individuals with normal HbA1c levels. Only a minority of the participants, around 10% of the total population, attained a TIR above 95%. These results emphasize the importance of considering TIR in addition to HbA1c for a comprehensive assessment of glycemic control in diabetes management.
Keywords: CGMS, time in range, HbA1c
| 30. Data Reveals 3 Out of 4 Indians Suffer From Vitamin D Deficiency; Young Adults Below 20 Most Affected|| |
Hemant Thacker, Ankita Shigwan, Rupal Shrimanker
Department of Clinical Research, Bhatia Hospital, Mumbai, Maharashtra, India
Background and Objective: Vitamin D is crucial for calcium metabolism, promoting healthy bone growth and strength. Emerging scientific evidence also suggests that vitamin D plays a role in reducing the risk of various chronic diseases, including diabetes, cancer, certain psychiatric conditions, and immune system disorders. The primary sources of vitamin D are natural sunlight exposure and dietary intake. The objective of this study was to assess the prevalence of vitamin D deficiency in young Indian adults.
Methodology: The study analyzed 500 individuals admitted to a tertiary healthcare center in Mumbai for various reasons to determine vitamin D deficiency. Out of these, 375 individuals were incidentally found to be deficient, representing a significant proportion of the total participants. Further data review revealed that 76% of the Indian population suffers from vitamin D deficiency, with 79% of men and 75% of women having lower than desirable levels of this vitamin in their bodies [Table 30.1].
Results: This observational study revealed that vitamin D deficiency was more prevalent among younger individuals, with the highest occurrence in the age group below 20 years, followed by those aged 21 to 40 years [Figure 30.1].
Conclusion: The study highlights the widespread prevalence of vitamin D deficiency, especially among the younger and middle-aged population, which may have significant implications for skeletal health and the development of chronic diseases later in life. Addressing this deficiency in the young population becomes crucial to prevent potential health risks in the future. The healthcare community faces the challenge of addressing this issue effectively. Fortification of multiple foods could be one approach, but supplementing sunshine exposure with oral supplements might be the most effective remedy.
| 31. Patient Profiling and Outcome Assessment of Vildagliptin And Dapagliflozin Fixed Dose Combination in Patients With Type 2 Diabetes Mellitus - A Real-World Retrospective Study in India|| |
Department of Scientific Services, USV Pvt. Ltd.
Background and Objective: Combination therapy of Sodium-Glucose Cotransporter 2 inhibitors (SGLT2i) and Dipeptidyl Peptidase 4 inhibitors (DPP4i) has shown to offer superior improvement in glycemic control compared to individual components in the treatment of type 2 diabetes mellitus (T2DM). This combination is also associated with benefits such as weight loss, reduced risk of hypoglycemia, and improved adherence to treatment. One such fixed-dose combination (FDC) oral anti-diabetic drug is vildagliptin (DPP4i) and dapagliflozin (SGLT2i). This study aims to evaluate the patient profile and assess the effectiveness and safety of vildagliptin + gapagliflozin FDC.
Methodology: Data was extracted and digitized from individuals with T2DM who had at least two follow-up visits between May 1, 2022, and January 31, 2023, at 72 selected centers in India. The collected information included demographics, medical history, diabetes duration and complications, medication history, and laboratory values. The study obtained clearance from an independent ethics committee on February 12, 2023.
Results: Data from 1587 individuals with T2DM who received treatment with vildagliptin + dapagliflozin FDC were analyzed. The majority of participants were male (65%), with an average age of 55.8 years (95% CI: 55.3 - 56.3). After six months of using the FDC, there was a significant decrease of 1.28% in HbA1c levels, indicating improved glucose control. The effectiveness of the FDC was consistent across different genders and age groups. Among those with high baseline HbA1c levels, 32.8% achieved glycemic control (HbA1c < 7%) within six months. Participants with T2DM duration of more than five years experienced a greater reduction in HbA1c (1.37%) compared to those with a duration of <=5 years (1.20%). Additionally, higher baseline HbA1c levels corresponded to a greater decrease in HbA1c. Adverse events were reported by 25 individuals (1.6%), and 58 individuals (3.7%) reported side effects. Only one person reported experiencing hypoglycemia.
Conclusion: The study demonstrates the effectiveness of vildagliptin + dapagliflozin FDC in reducing HbA1c levels among individuals with type 2 diabetes mellitus.
Keywords: DPP4i, fixed-dose combination, SGLT2i
| 32. Life Style Modification Improves HbA1C and Metabolic Health in Individuals With Obesity|| |
Hemant Thacker, Ankita Shigwan, Rupal Shrimanker
Department of Clinical Research, Bhatia Hospital, Mumbai, Maharashtra, India
Background and Objective: Regular exercise is known to improve insulin resistance and glycemic control, but its effectiveness in real-world programs varies. Laboratory studies have shown that exercise after breakfast improves postprandial glucose levels with subsequent meals, while exercise before breakfast enhances whole-body fat oxidation. However, it remains unclear whether these acute effects translate to greater improvements in metabolic health with exercise training. The objective of this study is to investigate whether exercise before or after breakfast leads to differential improvements in metabolic health and postprandial glycemic response.
Methodology: Forty-four individuals with obesity (average age 46 ± 12 years, BMI 35.1 ± 5.1 kg/m2) participated in a 12-week walking-based exercise program, which included two continuous and two interval sessions per week (lasting 30-60 minutes each). The interval sessions involved alternating 3 minutes at 85% of their maximum heart rate (HRmax) with 3 minutes at 50% HRmax. Participants were divided into two groups: one group exercised before breakfast (FAST), and the other group exercised after breakfast (FED) (n=22 participants per group). Body composition, HbA1c (glycated hemoglobin), blood lipids, and liver transaminases (ALT/AST) were measured before and after the intervention. Postprandial glucose responses were assessed in week 1 and week 12 using flash glucose monitoring.
Results: Both the FAST and FED groups showed high adherence (93% for FAST, 95% for FED) and compliance (85% for FAST, 88% for FED) with the exercise program. Body mass, BMI, waist-to-hip ratio, and HbA1c decreased similarly in both groups (all P >0.001, HbA1c P=0.01). However, ALT decreased significantly after FAST training (-16%; P=0.001) but not after FED training (-2%; P=0.720). In week 1, continuous exercise resulted in lower postprandial responses to lunch (FAST; P=0.064) and dinner (FED; P=0.047) compared to interval exercise. In week 12, the postprandial glucose responses to lunch and dinner were lower after interval exercise compared to week 1 (P=0.008).
Conclusion: Both pre- and post-breakfast exercise improved body composition and glycemic control. The postprandial-lowering effect of interval exercise was enhanced by free-living exercise. However, pre-breakfast exercise had a greater impact on liver biochemistry, making it potentially advantageous for individuals with obesity and fatty liver.
Keywords: Glycated hemoglobin, maximum heart rate, glucose monitoring
| 33. Diabetic Striatopathy – A Case Report|| |
Department of Diabetology, MGM Speciality Hospital, Srikalahasti, Andhra Pradesh, India
Introduction and Objective: Diabetic striatopathy, a movement disorder induced by long-standing poor control of diabetes mellitus, can manifest as chorea or ballism. We report a rare case of a 65-year-old woman presenting with involuntary movements in her left upper limb due to acute hyperglycemia. The objective of this case report is to describe the presentation, management, and outcome of this unique case, which showed negative imaging findings on MRI.
Case Presentation: A 65-year-old elderly lady with a history of long-standing diabetes and hypertension for the past 15 years presented with constant, uncontrolled, large amplitude, wild, and non-rhythmic movements in her left upper limb. The movements had a gradual onset and were progressive in nature, significantly affecting her daily routine and food intake. The patient's medical history revealed long-standing diabetes mellitus and hypertension, with suboptimal follow-up. Her current medications included a single pill combination of metformin 500 mg/glimepiride 1 mg taken twice daily and tab. Amlodipine 5 mg taken once daily. Clinical examination revealed L monoballismus, and her initial blood glucose level was markedly elevated at 559 mg/dl. MRI of the brain showed lacunar infarcts with cerebral atrophy. Notably, the MRI did not show the typical striatal hyperdensity or hyperintensity observed in most cases of diabetic striatopathy. The patient was treated with insulin and Tab. haloperidol, and after 72 hours, her abnormal movements reduced. Seven days into treatment, all medications except insulin were discontinued, and the patient continued to respond favorably [Table 33.1].
Discussion: Diabetic striatopathy (DS) is characterized by acute onset of chorea or ballism and is associated with hyperglycemic conditions. While most cases show striatal hyperdensity on CT or hyperintensity on T1-weighted MRI, our patient's imaging results were negative for these findings, making her case unique. DS is more prevalent in elderly females, possibly due to increased sensitivity of dopamine receptors in the striatum among estrogen-deficient postmenopausal women. It is more commonly associated with type 2 diabetes mellitus and non-ketotic hyperglycemia. The underlying mechanisms of DS include hyperglycemia-induced hyperviscosity, leading to ischemia and blood-brain barrier disruption, as well as intracellular acidosis, regional metabolic failure, and gamma-aminobutyric acid depletion. The mainstay of DS treatment involves controlling hyperglycemia and ensuring proper hydration to correct the metabolic imbalance. Haloperidol is commonly used as a monotherapeutic agent against DS-associated chorea, followed by Tetrabenazine, Risperidone, and Clonazepam. Clinicians should be aware of acute movement disorders like DS, and tight blood glucose control alone can help alleviate abnormal movements in such cases.
Keywords: Diabetic stratiopathy, hyperglycemia, FBS
| 34. Multifactorial Risk Reduction With Oral Semaglutide in the Treatment of Type 2 Diabetes|| |
Arjun Nair1, V. R. Aroda2, J. Eliasson3, L. L. Nielsen3, B. Malling3, J. J. Meier4, T. Vilsboll5, K. Khunti6
1Novo Nordisk, Bengaluru, Karnataka, India
2Brigham and Women's Hospital, Harvard Medical School, Boston, USA
3Novo Nordisk A/S, Søborg, Denmark
4St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany
5Steno Diabetes Center Copenhagen, Gentofte Hospital, University of Copenhagen, Herlev, Denmark
6Leicester Diabetes Centre, Diabetes Research Centre, Leicester General Hospital, Leicester, UK
Background and Objective: The objective of this exploratory analysis was to assess the efficacy of oral semaglutide (OS) in improving multiple cardiometabolic risk factors compared to various comparators in people with type 2 diabetes mellitus (T2DM).
Methodology: Participants with T2DM from the PIONEER clinical trials were randomly assigned to receive OS 14 mg with flexible dose adjustment in PIONEER 7, or comparators including empagliflozin 25 mg, sitagliptin 100 mg, liraglutide 1.8 mg, or placebo. This post hoc analysis evaluated the proportion of individuals achieving specific cardiometabolic endpoints, such as reductions in HbA1c by ≥1%, body weight by ≥5%, systolic blood pressure by ≥5 mmHg, LDL cholesterol by ≥0.5 mmol/L, or an increase in estimated glomerular filtration rate (eGFR) by ≥0 mL/min/1.73 m2, by the end of PIONEER 1-8 trials. The analysis also assessed the proportion of individuals achieving 2, 3, or 4 or more of these endpoints. The data was analyzed using a logistic regression model.
Results: A greater proportion of individuals achieved each endpoint with OS compared to the various comparators. Reductions in HbA1c by ≥1% were observed in 47.3% to 77.1% with OS, 32.8% to 51.4% with active comparators, and 8.5% to 23.7% with placebo. Reductions in body weight by ≥5% were seen in 30.8% to 49.8% with OS, 12.7% to 41.0% with active comparators, and 5.4% to 16.3% with placebo. Reductions in systolic blood pressure by ≥5 mmHg occurred in 47.9% to 62.5% with OS, 48.8% to 59.7% with active comparators, and 40.1% to 57.9% with placebo. Reductions in LDL cholesterol by ≥0.5 mmol/L were observed in 20.2% to 27.4% with OS, 13.7% to 21.1% with active comparators, and 12.7% to 21.7% with placebo. Increases in eGFR by ≥0 mL/min/1.73 m2 were seen in 45.1% to 54.6% with OS, 37.0% to 50.0% with active comparators, and 32.4% to 44.5% with placebo. Significantly greater proportions of individuals achieved improvements in 2, 3, or 4 or more endpoints with OS compared to comparators across all trials, except for the achievement of 2 endpoints with OS 14 mg vs liraglutide 1.8 mg in PIONEER 4 [Table 34.1].
Conclusion: Managing multiple risk factors is essential for reducing long-term risks in people with T2DM. Oral semaglutide demonstrated greater efficacy in improving multiple cardiometabolic risk factors compared to various comparators, indicating its potential in addressing the comprehensive cardiometabolic profile for people with T2DM.
Keywords: Cardiometabolic risk, diabetes, oral semaglutide
| 35. Gender Differences in Resting Heart Rate and Electrocardiographic Changes in Patients With Type 2 Diabetes Mellitus|| |
Aniket V. Inamdar
Samarpan Clinic, Omerga, Maharashtra, India
Background and Objective: Resting heart rate is an easily measured but essential indicator of cardiovascular diseases. Numerous studies have shown that a fast resting heart rate is a significant marker of increased morbidity and mortality among individuals with cardiovascular diseases, indicating that sympathetic over activity may contribute to the development of cardiovascular diseases and diabetes. The objective of this study was to investigate gender differences in resting heart rate and electrocardiographic changes in people with type 2 diabetes mellitus (T2DM).
Methodology: A total of 200 consecutive people with T2DM were included in the study. Diabetes mellitus was defined in accordance with the American Diabetes Association's definition. Baseline 12-lead electrocardiogram ECG was conducted on all individuals, and resting heart rate and Corrected QT Interval (QTc) were calculated from the ECG. Statistical analysis was performed using T-test, modified T-test, Mann-Whitney test, and ANOVA for analysis.
Results: The mean resting heart rate in males was 80.709 ± 1.426, and in females, it was 86.753 ± 2.218. The study revealed that females had a statistically significant higher resting heart rate than males (p=0.017). Females also exhibited a longer QTc interval on ECG compared to males (p=0.038).
Conclusions: Resting heart rate serves as an overall index of autonomic tone. An elevation in resting heart rate may indicate an imbalance in the autonomic nervous system, favoring sympathetic activation. Enhanced sympathetic activity has been linked to reduced insulin sensitivity, high blood pressure, obesity, subclinical inflammation, and metabolic syndrome, all of which are associated with the development of type 2 diabetes. In individuals with diabetes, a prolonged QTc is associated with autonomic neuropathy and ischemic heart disease, increasing the risk of sudden death. An epidemiological study from the Chicago Heart Association Detection Project in Industry Study reported that resting heart rate in middle age was positively associated with the diagnosis of diabetes and diabetes mortality in older age. Hormonal factors may contribute to sex differences in ventricular repolarization on ECG. More studies are needed to examine gender differences in electrocardiographic changes in people with type 2 diabetes mellitus.
Keywords: Heart rate, QTc, women