An overview of therapeutic options of obesity management in India: the Integrated Diabetes and Endocrinology Academy (IDEA) 2023 Congress update.

INTRODUCTION: With newer anti-obesity medications (AOMs) being introduced at a rapid pace, it is prudent to make a concise and updated clinical practice document that may help busy clinicians in daily clinical practice. A group of metabolic physicians, diabetologists, endocrinologists, and bariatric surgeons assembled during the Integrated Diabetes and Endocrine Academy 2023 Congress (IDEACON, July 2023, Kolkata, India) to compile an update of pharmacotherapeutic options for managing people with obesity in India. AREAS COVERED: After an extensive review of the literature by experts in different domains, this update provides all available information on the management of obesity, with a special emphasis on both currently available and soon-to-be-available AOMs, in people with obesity. EXPERT OPINION: Several newer AOMs have been shown to reduce body weight significantly, thus poised to make a paradigm shift in the management of obesity. While the tolerability and key adverse events associated with these AOMs appear to be acceptable in randomized controlled trials, pharmacovigilance is vital in real-world settings, given the absence of sufficiently long-term studies. The easy availability and affordability of these drugs is another area of concern, especially in developing countries like India.

Consensus on Current Landscape and Treatment Trends of Obesity in India for Primary Care Physicians.

Objectives: The objective of this consensus article was to form a list of expert recommendations and an easily adaptable algorithm for obesity management in India by primary care physicians (PCPs). Methods: A Delphi-based model was followed to form a list of the consensus recommendations. Consensus statements were created from the results of a literature review that were graded as per the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. After being evaluated by an expert panel comprising diabetologists, endocrinologists, cardiologists, bariatric surgeons, and gynecologists, the statements were revised and reevaluated by a larger group of practitioners, including PCPs and diabetologists, to arrive at a consensus. Results: The panel opined that obesity is increasing in prevalence in India and is projected to rise in the coming years. Body mass index and waist circumference were both recommended for better identification of people at risk of obesity-related comorbidities than either of them alone. The Edmonton Obesity Staging System (EOSS) was suggested as being most suitable for the assessment (staging) of obesity. A multidisciplinary team was considered invaluable for assessing and managing patients with obesity. The use of once-a-week semaglutide (2.4 mg) via the subcutaneous route was suggested as the first-choice anti-obesity treatment when pharmacotherapy is deemed necessary. An algorithm considering all these aspects was proposed. Conclusion: Obesity needs to be recognized as a significant contributor to other comorbidities. The diagnosis and management of obesity should be comprehensive and consider patient psychology, the presence or absence of comorbidities, available pharmacologic agents, and long-term outcomes. The proposed algorithm could help clinicians in this aspect and improve the overall outcomes. How to cite this article: Deshpande NR, Kapoor N, Dalal JJ, et al. Consensus on Current Landscape and Treatment Trends of Obesity in India for Primary Care Physicians. J Assoc Physicians India 2023;71(10):69-77.

Correlation of serum HDL level with HRV indices using multiple linear regression analysis in patients with type 2 diabetes mellitus.

AIMS/OBJECTIVES: To determine the correlation between serum HDL levels with HRV indices in patients with T2DM. MATERIALS AND METHODS: The study included 120 type 2 DM patients aged 35-65 years of either sex by simple random sampling. One-minute HRV was analyzed during deep breathing and fasting serum HDL levels was estimated in all patients. Data were analyzed using SPSS 20.0. Karl Pearson's correlation coefficient for relationship and Multiple linear regression analysis was applied for assessment of the influence of independent variables (HRV Indices) on a dependent variable (serum HDL levels). P < 0.05 was considered statistically significant. RESULTS: Significant negative correlation was observed between serum HDL levels with Mean HR (r = 0.7422, p < 0.001)), LFnu (r = -0.6172, p < 0.001) and ratio of LF/HF (r = 0.5333, p < 0.001). But significant positive correlation was observed between serum HDL levels with HFnu (r = 0.6438, p < 0.001), SDNN, (r = 0.7495, p < 0.001)), RMSSD (r = 0.6348, p < 0.001) and pNN50 % (r = 0.8187, p < 0.001). CONCLUSIONS: Our findings suggest that HDL-C level and all other HRV indices are dependent on each other in patients with T2DM. Most of these patients with low HDL-C level might be associated with autonomic imbalance; this in turn is detected by a simple bedside test of 1-minute HRV during deep breathing.

Obesity-friendly language.

This communication describes the style and content of obesity-friendly language, so as to create a positive and welcoming environment for the obese individual accessing health care. Attention to matters of language and conversation style will ensure better a relationship between the patient and provider and facilitate optimal outcomes.

Efficacy and Safety of Topical Solution of Diperoxochloric Acid for Neuropathic Diabetic Foot Ulcer: Results from a Phase 3, Multicentre, Randomized, Active-controlled, Parallel-group Study.

Diabetic foot ulcer (DFU), if untreated, accounts for lower-limb amputations affecting patients' quality-of-life. Diperoxochloric acid (DPOCL) is known to heal DFU by its antibacterial and fibroblast stimulating activity. This was a phase 3, multicentre, randomized, double-blind, active-controlled, parallel-group study conducted to evaluate the efficacy and safety of topic solution of DPOCL compared with isotonic sodium chloride solution (ISCL). Adult patients with type 1 or 2 diabetes with random blood glucose levels of <250 mg/dL, with ≤ than three full-thickness foot ulcers were enrolled. Primary efficacy endpoint was complete wound closure and secondary was wound surface area. Adverse events were analyzed as safety endpoint. Of 311 enrolled patients, 289 were randomized 1:1 to DPOCL (139) and ISCL (150) treatment (10-weeks [8-Visits]). Percentage of patients with complete wound closure at visit-8, were significantly higher (P = .0156) in DPOCL arm (76% [105/139]) compared to ISCL (62% [93/150]) arm. At end-of-study, mean wound surface area in DPOCL arm (0.639 cm2) was significantly lower (P = .0209) compared to ISCL (0.818 cm2) arm. One death was reported in control arm which was not considered as treatment-related. No important safety finding were observed. Results indicate that, DPOCL can be considered as effective and safe treatment option for DFU compared to ISCL, although future confirmatory studies are warranted.

Prescribing Patterns and Response to Antihyperglycemic Agents Among Novel Clusters of Type 2 Diabetes in Asian Indians.

Aim: To assess the prescribing patterns and response to different classes of antihyperglycemic agents in novel clusters of type 2 diabetes (T2D) described in India. Materials and Methods: We attempted to replicate the earlier described clusters of T2D, in 32,867 individuals with new-onset T2D (within 2 years of diagnosis) registered between October 2013 and December 2020 at 15 diabetes clinics located across India, by means of k-means clustering utilizing 6 clinically relevant variables. Individuals who had follow-up glycated hemoglobin (HbA1c) up to 2 years were included for the drug response analysis (n = 13,247). Results: Among the 32,867 participants included in the study, 20,779 (63.2%) were males. The average age at diagnosis was 45 years and mean HbA1c at baseline was 8.9%. The same four clusters described in India earlier were replicated. Forty percent of the study participants belonged to the mild age-related diabetes cluster, followed by insulin-resistant obese diabetes (27%), severe insulin-deficient diabetes (21%), and combined insulin-resistant and insulin-deficient diabetes (12%) clusters. The most frequently used antihyperglycemic agents were sulfonylureas, metformin, and dipeptidyl peptidase-4 inhibitors apart from insulin. While there were significant differences in HbA1c reduction between drugs across clusters, these were largely driven by differences in the baseline (pretreatment) HbA1c. Conclusions: In this new cohort, we were able to reliably replicate the four subtypes of T2D earlier described in Asian Indians. Prescribing patterns show limited usage of newer antihyperglycemic agents across all clusters. Randomized clinical trials are required to establish differential drug responses between clusters.

Type 2 Diabetes in Women: Differences and Difficulties.

BACKGROUND: Lifestyle modification, along with medication, has improved the quality of life of patients with type 2 diabetes (T2D), but the treatment of diabetes in women still lacks a gender-centric approach. METHODS: Expert opinions to improve diabetes management in women were collated from the open discussion forum organized by the sixth Jothydev's Professional Education Forum Diabetes Convention, which included global diabetes care experts and the general public. The review is also based on the studies published in electronic databases such as PubMed and Google Scholar that discussed the problems and challenges faced by the Indian diabetes care sector in treating women with diabetes. RESULTS: The complex interplay of biological, socioeconomic, psychosocial, and physiological factors in women with type 2 diabetes has not been well addressed to date. Biological factors such as neurohumoral pathways, sex hormones, genetic predisposition as well as gender-based environmental and behavioural differences must be considered for modern personalized diabetes treatment. Most importantly, pregnant women with diabetes deserve special attention. This vulnerable phase has a marked impact on the future health of both the mother and the offspring. CONCLUSION: The review provides an overview of the challenges and issues that exist in the clinical management of diabetes and its complications among women in India. Women-centric clinical approaches should be encouraged for the effective management of diabetes in Indian women.

Suboptimal glycemic control among subjects with diabetes mellitus in India: a subset analysis of cross-sectional wave-7 (2016) data from the International Diabetes Management Practices Study (IDMPS).

OBJECTIVE: To assess the real-world management practices of subjects with type 2 diabetes mellitus (T2DM) and type 1 diabetes mellitus (T1DM) in India. METHODS: This cross-sectional study was conducted between 7 March 2016 and 15 May 2016 in India as part of the seventh wave (2016) of the International Diabetes Management Practices Study (IDMPS). Adult subjects with T1DM or T2DM visiting physicians during a 2-week recruitment period were included. RESULTS: A total of 55 physicians included 539 subjects who met eligibility criteria. Of 495 subjects with T2DM, 303 were treated with oral glucose lowering drugs (OGLDs) only, 158 were treated with OGLD + insulin, and 27 received insulin only. Among 44 subjects with T1DM receiving insulin, 13 (29.5%) were also treated with OGLD therapy. The most commonly used insulin regimens were basal alone (69/184; 37.5%) and premixed alone (63/184; 34.2%) in subjects with T2DM, and basal + prandial insulin (24/44; 54.5%) in subjects with T1DM. Proportions of subjects achieving glycemic targets were low [glycated haemoglobin (HbA1c) <7%: T1DM = 7.3% (3/44), T2DM = 25.2% (106/495); as targeted by the treating physician: T1DM = 31.8% (14/44), T2DM = 32.1% (59/185); global target: T1DM = 4.8% (2/42) and T2DM = 1.7% (8/482)]. In subjects with T2DM, HbA1c <7% was noted in 11/22 subjects receiving insulin only and 76/260 receiving only OGLDs. Lack of experience in self-managing insulin dosing, poor diabetes education and failure to titrate insulin dosages were the main reasons for non-achievement of glycemic targets. CONCLUSION: Timely insulinization, education and empowerment of people with diabetes may help improve glycemic control in India.

Consensus Statement on Use of Ambulatory Glucose Profile in Patients with Type 2 Diabetes Mellitus Receiving Oral Antidiabetic Drugs.

Glucose monitoring is an important aspect of diabetes care. The traditional methodologies of blood glucose monitoring such as fasting plasma glucose, post prandial glucose, glycosylated hemoglobin and self-monitoring of blood glucose do not adequately address hypoglycemia and glycemic variability, which are two important risk factors for diabetes-related complications. Ambulatory glucose profile (AGP) developed from a continuous glucose monitoring system is a simplified report, with standardized statistics and targets and visual representation of time in standardized glycemic ranges, glucose variability, and glycemic exposure over a single 24-h day. The role of AGP in T2DM patients who are on oral anti-diabetic drugs (OADs) is still not clearly defined. An expert group of endocrinologists and diabetologists met in Pune, India to discuss the role of AGP in T2DM patients on OADs. This article aims to discuss the consensus of the expert group on the role of AGP in T2DM patients on OADs and also reviews the various aspects of AGP and its interpretation; and the available evidences for disease management including treatment options based on AGP report.

A tale of two risks: smoking, diabetes and the subgingival microbiome.

Although smoking and diabetes have been established as the only two risk factors for periodontitis, their individual and synergistic impacts on the periodontal microbiome are not well studied. The present investigation analyzed 2.7 million 16S sequences from 175 non-smoking normoglycemic individuals (controls), smokers, diabetics and diabetic smokers with periodontitis as well as periodontally healthy controls, smokers and diabetics to assess subgingival bacterial biodiversity and co-occurrence patterns. The microbial signatures of periodontally healthy smokers, but not diabetics, were highly aligned with the disease-associated microbiomes of their respective cohorts. Diabetics were dominated by species belonging to Fusobacterium, Parvimonas, Peptostreptococcus, Gemella, Streptococcus, Leptotrichia, Filifactor, Veillonella, TM7 and Terrahemophilus. These microbiomes exhibited significant clustering based on HbA1c levels (pre-diabetic (<6.5%), diabetic (6.5-9.9%), diabetics >10%). Smokers with periodontitis evidenced a robust core microbiome (species identified in at least 80% of individuals) dominated by anaerobes, with inter-individual differences attributable largely to the 'rare biosphere'. Diabetics and diabetic smokers, on the other hand, were microbially heterogeneous and enriched for facultative species. In smokers, microbial co-occurrence networks were sparse and predominantly congeneric, while robust inter-generic networks were observed in diabetics and diabetic smokers. Smoking and hyperglycemia impact the subgingival microbiome in distinct ways, and when these perturbations intersect, their synergistic effect is greater than what would be expected from the sum of each effect separately. Thus, this study underscores the importance of early intervention strategies in maintaining health-compatible microbiomes in high-risk individuals, as well as the need to personalize these interventions based on the environmental perturbation.

Role and Relevance of Blood Pressure Variability in Hypertension Related Co-morbidities.

Despite maintaining mean blood pressure at optimal levels, cardiovascular complications still occur in hypertensive patients. Blood pressure variability (BPV) has been implicated as a prominent factor responsible for incurring this additional risk. In this review we attempted to generate a consensus on the importance of BPV in the hypertension management and to evaluate different therapeutic options available to reduce BPV. Panel comprising of 11 leading experts from India in different areas of clinical practice (including nephrology, diabetes and endocrinology, cardiology, and critical care medicine) was convened. The board reviewed up to date literature on BPV, shared personal experiences from their clinical practice, and debated their opinions on the significance of BPV in hypertension management and also on various therapeutic options available to control it. The reviewers agreed that BPV is frequently observed in hypertensive individuals and it is a critical factor in hypertension management. Blood pressure variability can be measured by ambulatory blood pressure monitoring, home blood pressure monitoring, and office blood pressure monitoring. Members concurred that variations in blood pressure that are 10 standard deviations above the mean blood pressure should be considered as pathologically significant and such variations should be reduced using pharmacological therapies. The board opined that Angiotensin II Receptor Blockers,Calcium Channel Blockers etc such as Olmesartan, Nifedipine can be used to reduce BPV. As a way forward, the panel recommends to bridge the evidence gap that establishes a possible direct relationship between BPV and cardiovascular complications. Blood pressure variability has paramount role in the current hypertension management scenario. To reduce disease burden and increase quality of life of hypertensive individuals, physicians should consider lowering BPV along with physiological BP levels.

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Karnataka cohort of the A1chieve study.

BACKGROUND: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. MATERIALS AND METHODS: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Karnataka, India. RESULTS: A total of 2243 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 1855), insulin detemir (n = 211), insulin aspart (n = 111), basal insulin plus insulin aspart (n = 16) and other insulin combinations (n = 40). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.2%) and insulin user (mean HbA1c: 9.0%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -1.4%, insulin users: -1.7%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. CONCLUSION: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.