Type 2 Diabetes Mellitus In India Research Articles

Pragmatic Study Design to Assess the Effect of a mHealth Application on Empowerment of Noninsulin Treated Type 2 Diabetes People in a Low- and Middle-income Setup

Background: In low- and middle-income countries (LMICs), such as India, self-monitoring of blood glucose (SMBG) for people living with type 2 diabetes mellitus (T2DM) faces many barriers. mHealth applications that combine blood glucose (BG) assessment and the provision of actionable information can help overcome current challenges. Pragmatic study protocols assessing the medical value of mobile SMBG applications to deal with LMIC-specific challenges are missing. Aims and Objectives: This study will assess the impact of a mHealth application on diabetes empowerment using the Diabetes Empowerment Scale-Short Form questionnaire in noninsulin-treated people with T2DM in India. Methods: An observational, single-arm, prospective study will be conducted among adults (n = 100) with T2DM who have not been using a BG meter before and were on diet, exercise, or noninsulin antidiabetic therapy. After enrollment (baseline) and an 8-week control phase, the people participating in the study will receive the mobile phone-based BG assessment devices and will receive a training for the application. During the observational period of 12 weeks (20 weeks after baseline), the subjects will monitor their BG ranges with the devices and the mobile application. At baseline and weeks 8, 14, and 20, diabetes empowerment will be assessed as primary outcome. Health literacy, diabetes treatment satisfaction, and user experience, among others, will be examined as secondary outcomes. Discussion: Mobile applications have the potential to improve diabetes care due to their higher reach, but pragmatic study designs are needed to evaluate the effectiveness. Conclusions: The results of this pragmatic study will provide more patient-reported insights on the impact of mobile applications on diabetes self-management in LMIC.

Precision of Michigan Neuropathy Screening Instrument (MNSI) Tool for the Diagnosis of Diabetic Peripheral Neuropathy Among People with Type 2 Diabetes-A Study from South India.

Diabetic peripheral neuropathy (DPN) is one of the risk factors for foot-related complications among people with type 2 diabetes mellitus (T2DM). Hence, we aimed to validate the Michigan Neuropathy Screening Instrument (MNSI) tool against biothesiometer with a cut-off value of ≥25 V and also to determine the cut-off point of MNSI score for the diagnosis of diabetic neuropathy among people with T2DM in India. A cross-sectional study was conducted among 357 people with T2DM in a tertiary care centre for diabetes in Chennai, South India. The eligible study participants underwent testing with a biothesiometer and the MNSI tool was administered. The patient version tool of MNSI was translated to the local language, Tamil. The MNSI scores (1, 1.5, 2, and 2.5) were compared with biothesiometer value. For the MNSI scores of less than 1, 1.5, 2, and 2.5, sensitivities were 97.6%, 97.6%, 96.8%, and 77.8% and specificities were 76.6%, 77.9%, 85.7%, and 88.3% respectively. The cut-off value of MNSI score was derived as two with AUC of 0.934. The sensitivity was 96.8% and the specificity was 85.7% with 89.6% accuracy. The high sensitivity indicates the positive cases are diagnosed correctly. There is no validated tool available for detection of DPN in Indian population. The Indian version of MNSI tool was found to be effective for screening diabetic neuropathy among people with T2DM. The MNSI tool was found to be reliable, convenient, and non-invasive for diagnosis of DPN and can be used in routine clinical settings.

Early-onset Type 2 Diabetes Mellitus and Cardiometabolic Risk in India

Introduction: The Indian patient phenotype with early-onset type 2 diabetes mellitus (T2DM) merits a more holistic understanding of the cardiometabolic risk profile. As per the principles of precision medicine, such understanding can help appraise the clinical place of interventions like sodium-glucose cotransporter-2 inhibition (SGLT2-i), for this population. Methodology: This observational study represents cases with T2DM, aged ≤40 years, who were newly initiated on empagliflozin on top of standard therapy. Analysis was performed for demographics and clinical characteristics at baseline and 3 months following empagliflozin use. Parameters for analysis included clinical and laboratory indicators of glycemic control, adiposity, insulin sensitivity, inflammation, and derived indicators for cardiometabolic risk. Descriptive statistics have been used for the analysis. Further, subgroups by body mass index (BMI) status (< or ≥25 kg/m2) have been compared for certain continuous variables, using an unpaired t-test. Results: The study included 70 patients, with a mean age of nearly 36 years. The mean BMI was 25.57 kg/m2; approximately 43% of patients had a BMI ≥25 kg/m2. The nonobese patients had a higher triglyceride-glucose index and lower fasting insulin levels, compared to obese patients. The risk of advanced nonalcoholic steatohepatitis was low in this population. The addition of empagliflozin to background therapy improved the HbA1c level by 1.21% with 44% goal-achievement and other metabolic parameters. Weight loss and anthropometric changes were modest. Empagliflozin use was associated with meaningful improvements in cardiometabolic parameters, including triglyceride-glucose index, atherogenic index of plasma, homeostatic model assessment for insulin resistance, quantitative insulin-sensitivity check index, visceral adiposity index, Fibrosis-4 index, and aspartate transaminase-to-platelet ratio index scores, in this population. Insulin resistance remained higher than normal in most patients, despite improvement with empagliflozin use over 3 months. Conclusion: The study findings for people with early-onset T2DM in India indicate: (1) the need for opportunistic screening for T2DM at an earlier age; (2) a high prevalence of insulin resistance regardless of obesity status; (3) meaningful improvements in overall cardiometabolic risk profile with SGLT2-i use; and (4) the importance of long-term optimization of diabetes care in this population.

707-P: Effectiveness of Breathe Well-Being Diabetes Reversal Program in Achieving Diabetes Remission

Introduction: Breathe Well-being Diabetes Reversal Program (BDRP) provides personalized Lifestyle Management (LSM) including coaching on diet and exercise as needed by individuals with type 2 diabetes mellitus (T2DM) along with tracking their blood glucose levels, weight, and physical activity. Objective: To evaluate the effectiveness of BDRP for achieving remission in individuals with T2DM in India. Methodology: This observational study had three cohorts (1:1:1) who were treated with: (1) BDRP with doctor-prescribed medication, (2) BDRP with doctor-prescribed medication and personalized stress reduction module, and (3) Only doctor-prescribed medication (control group) . Program adherence level was categorized as high (H: >70%) , medium (M: ≥50%-<70%) , and low (L: <50%) ; H and M data of cohorts 1 and 2 are presented here. Program was provided for 4 months, and individuals followed up at 7, 10, 13, 16, and 19 months. Informed consent was obtained. Results: The study included 181 individuals with an average age of 53.1 years, of which 1 (55.8%) were male. Overall, 46.7% (28) and 54.1% (33) individuals in cohorts 1 and 2 showed H and M adherence. Cohorts 1 and 2 showed 1.0% and 1.3% average HbA1c reduction vs. 0.3% with cohort 3 (overall population) after 4 months. At 4 months, in cohort 1, HbA1c levels <6.5% were observed in 32.1% individuals, which increased to 60.7%, 67.9%, and 78.6% at 7, 10, and 19 months vs. 36.4% individuals in cohort 2, which increased to 51.5%, 69.7%, and 81.8% at 7, 10, and 19 months, respectively. In cohorts 1 and 2, medication withdrawal was observed in 89.3% and 90.9% individuals at 13 months which was maintained up to 19 months. Conclusion: BDRP was effective in achieving remission in individuals with T2DM in India. BDRP with personalized stress reduction module had better outcomes comparatively. Digital therapeutics could be a potential approach in achieving diabetes remission in Indian settings. Disclosure P.K.Goyal: None. S.K.Patra: Employee; Breathe Well-being. A.Kaicker: None. R.Verma: None. S.Goel: Employee; Breathe Well-being. S.Rehman: None. R.Jangid: None. V.Madhusudhana: None.

A retrospective, non-interventional, electronic medical record based real world data analysis in patients suffering from pruritus in type 2 diabetes mellitus

<p class="abstract"><strong>Background: </strong>There is limited data highlighting the association of pruritus with Type 2 Diabetes Mellitus (T2DM). This was the first Electronic Medical Record (EMR) based real-world observational study on the demographics, clinical characteristics, associated risk factors and treatment(s) of pruritus in T2DM in India.</p><p class="abstract"><strong>Methods:</strong> EMR data of patients was retrospectively analysed with a baseline (V1) visit and two or more follow-up visits between June 2014-December 2019.</p><p class="abstract"><strong>Results: </strong>Majority of patients were 40-64 years old and mainly females (57%). Body mass index and co-morbidity data indicated a trend of obesity and hypertension. Observed HbA1c values were high (mean value of 9%). Majority of the patients were on hydroxyzine. Miconazole, fluconazole and corticosteroids were prescribed in 40% patients. Correlation between HbA1c levels with clinical pruritus was noted.</p><p class="abstract"><strong>Conclusions: </strong>Management of glycaemia along with timely dermatological intervention is needed for pruritus relief in T2DM, the use of antihistamines; in particular, hydroxyzine, should be further evaluated.</p>

First-in-Class Oral Semaglutide: Overcoming Barriers of Incretinisation in the Indian Context.

Despite the availability of multiple therapeutic options and strategies, patients with type 2 diabetes mellitus (T2DM) the world over have inadequate glycaemic control and India is no exception. Patients with T2DM in India have benefitted from glucagon-like peptide-1 analogues similar to that of patients from other parts of the world. However, subcutaneous treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is limited by their injectable mode of administration. The present review highlights barriers to incretinisation with GLP-1RAs and the role of first-in-class oral semaglutide in the Indian context and provides guidance to physicians on its initiation and uses.

Expert Opinion About the Pharmacoeconomic Edge of Low-Cost Dapagliflozin in Type 2 Diabetes Mellitus in Indian Clinical Settings.

BackgroundThis study aimed to understand the attitudes, beliefs, and concerns of physicians across India regarding the economic burden of diabetes and subsequently the cost-effectiveness of low-cost dapagliflozin for the management of patients with uncontrolled type 2 diabetes mellitus (T2DM) on background metformin therapy in Indian clinical settings.MethodA cross-sectional questionnaire survey was conducted among physicians treating people with T2DM with or without complications. The questions covered the general aspects of affordability and adherence to diabetes medications as well as specific details of low-cost dapagliflozin and its cost-effectiveness.ResultsIn total, 844 physicians provided a response to the survey questionnaire. The physicians who participated in the study included diabetologists, endocrinologists, cardiologists, consulting physicians, and family physicians. A majority of the physicians (53%) opined that only 10%-30% of their patients can afford the cost of newer antidiabetic medicines, while 25% of the physicians mentioned that <10% of their patients had issues related to affordability. Further, 39% of the physicians opined that 20%-40% of their patients discontinue the medicines due to high cost. Most of the physicians (95%) agreed that due to the low cost of dapagliflozin, it can be used for the primary prevention of heart failure in patients with T2DM in India. Similarly, 98% of the physicians agreed that it can be used for the treatment of heart failure in patients with or without T2DM in India. A majority of these physicians (93%) responded that switching from expensive sodium/glucose cotransporter-2 inhibitors (SGLT2i) to low-cost dapagliflozin is a long-term cost-effective management of T2DM. In total, 98% of the physicians agreed that low-cost dapagliflozin has the characteristics of an ideal SGLT2i because of its metabolic benefits, cardioprotection, nephroprotection, and potential cost-effectiveness.ConclusionThis survey-based study indicates that dapagliflozin is an effective and cost-saving therapy for patients with T2DM and complications. Low-cost dapagliflozin can revolutionize the treatment of T2DM in the Indian setting.

Effect of Gliclazide or Gliclazide plus Metformin Combination on Glycemic Control in Patients with T2DM in India: A Real-World, Retrospective, Longitudinal, Observational Study from Electronic Medical Records.

BackgroundThe efficacy of gliclazide has been reported in clinical trials in India. However, real-world data on the effectiveness of gliclazide in India is unavailable.ObjectiveTo provide real-world evidence regarding the effectiveness of gliclazide or gliclazide + metformin fixed-dose combination or separate medications, used either as monotherapy or as the latest add-on to other antihyperglycemic agents in reducing glycated hemoglobin (HbA1c) levels in Indian patients with type 2 diabetes mellitus (T2DM).MethodsElectronic medical record data of adult patients who were diagnosed with T2DM who were newly initiated on or had been prescribed gliclazide or gliclazide + metformin combination for < 30 days as monotherapy or as add-on therapy to other antihyperglycemic agents, and had HbA1c ≥ 6.5% were retrospectively analyzed. Mean change in HbA1c from baseline was the primary endpoint. Secondary endpoints were assessment of dosages and formulations of gliclazide or gliclazide + metformin prescribed in the HbA1c spectrum and antihyperglycemic agents to which gliclazide or gliclazide + metformin was added as an adjunct. Readings were obtained before initiating gliclazide or gliclazide + metformin and after at least 90 days of treatment with gliclazide or gliclazide + metformin.ResultsIncluded patients (n = 498) were categorized into gliclazide only (n = 66), gliclazide + metformin only (n = 179), gliclazide add-on (n = 169), and gliclazide + metformin add-on (n = 84) groups. Mean (95% confidence interval [CI]) change in HbA1c among patients with baseline HbA1c > 7% was − 0.8% (− 1.26, − 0.34) in gliclazide only group; − 1.6% (− 1.89, − 1.31; p < 0.001) in gliclazide + metformin group; − 1.2% (− 1.50, − 0.90; p < 0.001) in add-on gliclazide group; and − 1.4% (− 1.75, − 1.05; p < 0.001) in add-on gliclazide + metformin group. Gliclazide once daily was the most prescribed regimen in the gliclazide only group (72.7%), with 60 mg being the most prescribed modified-release dose (62.5%). Gliclazide + metformin twice daily was the most prescribed regimen in the gliclazide + metformin group (69.3%) with 80 mg + 500 mg being the most prescribed immediate-release dose (62.9%). Gliclazide and gliclazide + metformin were most added as an adjunct to existing prescriptions of biguanides (83.4%) or insulin (64.3%), respectively.ConclusionGliclazide or gliclazide + metformin prescribed as mono- or add-on therapy during routine clinical practice effectively reduced HbA1c in Indian patients with T2DM, thus validating the use of gliclazide and gliclazide + metformin for managing T2DM in India.

Assessment of Knowledge, Attitude and Practices of Medical Officers in Primary Health Centres Regarding Type 2 Diabetes Mellitus

Background: Health education is an integral part of Type 2 diabetes mellitus (T2DM) management, as it can be prevented and controlled by the implication of appropriate interventions. The aim of the study was to assess the knowledge, attitude, and practice (KAP) of medical officers (MOs) in primary health centres (PHC) regarding T2DM.&#x0D; Materials and methods: The 104 medical officers (MOs) with an experience of £2 years of medical practice were included in the study. A self-completion questionnaire, designed to be completed within 10-15 minutes, was developed to analyse the KAP of the MOs regarding T2DM.&#x0D; Results: Among the 104 MOs, 14 had knowledge about the prevalence of T2DM in India. Among the risk factors, obesity (71), physical inactivity (31), family history (43), and hypertension (15) were identified by the MOs. The microvascular complications, including retinopathy (77), nephropathy (63), and neuropathy (49) were stated by the physicians. However, the physicians were less aware about the macrovascular complications. As few as 23 physicians included HbA1c test as one of the diagnostic methods, 43 physicians included HbA1c to monitor the glycemic levels. More than half (55) of the physicians prescribed appropriate medications for the treatment of T2DM.&#x0D; Conclusions: The MOs had considerable knowledge and attitude about T2DM, however due to lack of facilities at the PHCs, the practice of MOs in the management of T2DM is poor. Education programmes to expand the understanding of the MOs regarding T2DM and initiatives to advance the facilities at PHCs are essential to manage T2DM in India. Keywords: Type 2 Diabetes Mellitus&#x0D; J MEDICINE JUL 2019; 20 (2) : 63-67

Insights on Medical Nutrition Therapy for Type 2 Diabetes Mellitus: An Indian Perspective.

It is critical to integrate medical nutrition therapy (MNT) provided by a registered dietician (RD) into primary care of type 2 diabetes mellitus (T2DM). This is necessary to achieve the goals of improving overall metabolic measures beyond calorie restriction and weight loss. Misconceptions about nutrition in T2DM add to the challenges of executing MNT in a culturally sensitive population. The current review provides insights into MNT for the prevention and management of T2DM in India, based on both evidence and experience. It revisits historical Indian studies and provides information on appropriate dietary intake of carbohydrates (60–70%), proteins (~ 20%) and fats (10%) that will be acceptable and beneficial in an Indian T2DM population. It discusses nuances of types of carbohydrates and fats and explains associations of increased dietary fiber intake, balanced intake of low and high glycemic index foods and substitution of saturated fats with plant-based polyunsaturated fats in improving outcomes of T2DM and attenuating risk factors. The article also deliberates upon special patient populations with comorbid conditions and diseases and the necessary adjustments needed in their nutritional care. It outlines a step-wise approach to MNT involving a careful interplay of nutrition assessment, diagnosis, individualization and patient counseling. Overall, the success of MNT relies on providing accurate, acceptable and appropriate dietary choices for continued patient adherence. Collaborative efforts from diabetologists, endocrinologists, internists and RDs are required to prioritize and implement MNT in diabetes practice in India.Funding: Signutra Inc.

Distinct Predictors and Comorbidities in Early Onset Type 2 Diabetes Mellitus Among Asian Indians.

The incidence of type 2 diabetes mellitus (T2DM) is increasing worldwide, and the age of disease onset is falling. Although there is rising prevalence of early onset T2DM in India, little is known about their clinical characteristics and cardiovascular risks profiles. The aim of this study was to address this knowledge gap by comparing the characteristics of early onset T2DM and usual onset T2DM patients from our clinic population in India. We studied the clinical and biochemical parameters of 98 consecutive early onset T2DM patients of age <45 and <5 years of disease duration and compared those parameters with 86 consecutive usual onset T2DM patients of age >50 years and similar disease duration. There was a strong component of family history of T2DM in early onset T2DM patients; however, no difference was observed in body mass index or waist circumference between the groups. When compared with usual onset group, the early onset T2DM patients were more hypertriglycedemic, with higher total cholesterol, higher total cholesterol/high-density lipoprotein (HDL) ratio, higher low-density lipoprotein levels, and lower HDL cholesterol. Early onset T2DM patients showed significantly worse glycemic control and rapid decline in insulin secretion compared with usual onset T2DM patients. Our results demonstrate that early onset T2DM in Asian Indians appears to be a disease phenotype with adverse risk factors having poor glycemic control and longer disease duration demanding strategies for novel clinical management.

A study to evaluate the prevalence of hypogonadism in Indian males with Type-2 diabetes mellitus.

Background:A high prevalence of hypogonadism in men with Type-2 diabetes mellitus (T2DM) has been reported worldwide.Objectives:To evaluate the prevalence of hypogonadism in Indian males with T2DM and assess the primary and secondary hypogonadism along with androgen deficiency.Materials and Methods:In this cross-sectional study, 900 men with T2DM were evaluated using androgen deficiency in aging male questionnaire. They were screened for demographic characteristics, gonadal hormone levels, lipid profile, and glycosylated hemoglobin.Results:The prevalence of hypogonadism in T2DM patients was found to be 20.7% (186 out of 900). Hypogonadism was of testicular origin (primary) in 48/186 (25.8%) patients, of pituitary or hypothalamic origin (secondary) in 14/186 (7.53%), and remaining 124/186 (66.67%) patients were found to have low testosterone with the inappropriate normal level of luteinizing hormone and Follicle-stimulating hormone. 451/900 (50.1%) patients were only symptomatic but had normal testosterone levels. Further 263 patients out 900 were asymptomatic, of which 51/900 (5.7%) patients had low levels of testosterone and 212/900 (23.5%) patients had normal testosterone level without symptoms. There were no deaths or other serious adverse events except mild pyrexia which was not related to the study.Conclusion:Hypogonadism diagnosis, at times, might not be validated with the help of androgen deficiency questionnaire or symptoms only. Given the large number of patients of T2DM in India, the incidence of hypogonadism is more in diabetic patients as compared to the general population. Hence, implementation of screening programs in diabetic patients is necessary to understand and detect individuals with low serum total testosterone at any early stage and to supplement testosterone accordingly.

Prescribing Pattern of Oral Antihyperglycaemic Drugs, Rationality and Adherence to American Diabetes Association (ADA) Treatment Guidelines among Type 2 Diabetes Mellitus (T2DM) Postmenopausal Women.

Oral antihyperglycaemic prescription trends keep on changing and thus the drug prescription trend study may prove to be powerful exploratory tool for health care providers. To investigate trends in prescriptions of oral antihyperglycaemic drugs (OHDs) among postmenopausal women suffering from T2DM in India and evaluate the rationality and adherence to ADA treatment guidelines. An observational, cross-sectional descriptive prescription audit (n=500) was carried. Postmenopausal women were interviewed in their local language using pre-tested pre validated questionnaire after verbal informed consent at a teaching tertiary care hospital of north India. Oral antihyperglycaemic drugs (OHDs) drugs were categorized as per the pharmacological classification. Adherence to available clinical practice guidelines/recommendations issued under American Diabetes Association (ADA) 2015 Guidelines as well as rationality of these prescriptions were assessed using WHO Guide to Good Prescribing. Mean age of the study population was 58.14±12.86. Mean duration since menopause was 5.3 years and of T2DM was 9.5 years. A 93.4% of the prescriptions had only OHDs whereas 6.6% of the prescriptions had various insulin preprations + OHDs (p<0.0001). Biguanides followed by sulfonylureas, thiazolidinediones, DPP-inhibitors and alpha-glucosidases inhibitor were prescribed in 85.6%, 59.8%, 26.6%, 26% and 12.2% respectively as monotherapy or in combination. Among biguanides, metformin was the most frequently prescribed OHDs. In spite of black box warning on pioglitazone, it was prescribed in 26.6% as FDC. However, clear increase use of vidagliptine was noticed upto 26%. Among combinations most frequent was metformin plus glimipride followed by voglibose plus metformin, whereas, among FDC, metformin plus glimipride followed by metformin plus vidagliptine were most frequently prescribed. Metformin was the most common OHDs to be prescribed followed by glimepiride. Although pioglitazone still continues to be prescribed after safety alert but apparently it appears that the share of pioglitazone has been shifted to vidagliptin or combinations like metformin plus glimipride. Polypharmacy, high use of FDC, & prescription by brand names were some of the irrationalities. Relatively low adherence to ADA treatment guidelines was observed.

Identification of barriers for adherence to exercise in type 2 diabetes mellitus—a cross sectional observational study

Background: Regular exercise improves blood glucose control and can prevent or delay type 2 diabetes mellitus (T2DM) related complications. Physical activity can help persons with T2DM to build self esteem and positive self image which are foundations of one’s quality of life. Exercise in T2DM can be defined as a planned and structured physical activity in order to improve or maintain one or more elements of physical fitness. Despite that the adherence to regular exercise recommendation in T2DM in India is not known. Purpose: The purpose of this study is to identify and rank gender wise barriers associated towards exercise adherence among persons with type 2 diabetes mellitus. Methods:A cross-sectional observational study was conducted from June 2014 to September 2014 at out patient department of three of the secondary care general hospitals in Nadiad and Anand, Gujarat state, India. A sample of 200 persons (mean age 45.9± 5.2 years) with type 2 diabetes mellitus were analyzed for 30minutes regular exercise 3 to 5 times per week. Data were obtained through personal interview and questionnaire. Datawere analysed using descriptive statistics. The informed consent was taken before the study commencement from every person with T2DM. Results: The important finding from this study is that the barrier for regular exercise differs among gender. Lack of time, lack of interest, lack of awareness about the importance of regular physical activity in controlling T2DMare the most common barriers in males. Family commitment, lack of time and lack of social support are most common barriers in females. Only 18% (n= 36) have the habit of doing regular exercise. Conclusion(s):While recommending exercise strategies, gender should be considered and strategy plans are framed accordingly. Implications: Strategies should be aimed at overcoming internal as well as external barriers in doing exercise in persons with T2DM.

An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India).

Objective:The primary objective of this study is to estimate the prevalence of chronic kidney disease (CKD) among type 2 diabetes mellitus (T2DM) patients in India.Materials and Methods:This cross-sectional, observational, epidemiological, multi-center, study is enrolling T2DM patients of either gender aged 30 years or above. This study aimed to enroll a total of 3000 T2DM patients at 30 participating hospitals/clinics across India and the data from a planned interim analysis of 1500 patients are presented here. The primary endpoint of the study is to estimate proportion of T2DM patients with CKD (glomerular filtration rate [GFR] <60 ml/min/1.73 m2 or albumin creatinine ratio [ACR] ≥30 mg/g or ≥3 mg/mmol or both). Routine treatment, as administered by the treating physician, was continued without any study specific intervention. Patients’ data pertaining to demographic characteristics, medical history, current medication and physical examination were recorded. The blood/plasma and urine samples, were collected for estimation of hemoglobin A1c, microalbuminuria, serum creatinine, urine creatinine, and routine urine analysis. ACR was calculated from urine creatinine and albumin while GFR was estimated by using a modification of diet in the renal disease equation.Results:Study recruited 1500 patients from 18 centers across India. The study population included 840 (56.05%) males. Mean age, body mass index and systolic blood pressure were 55.1 years, 27.4 kg/m2 and 134.5 mmHg respectively. The mean duration of diabetes was 102.2 months. History of co-morbid diseases such as dyslipidemia, hypertension, microvascular complications and macrovascular complications was present in 657 (43.8%), 655 (43.7%), 268 (17.9%) and 104 (6.93%), respectively. This interim analysis revealed that about 46% of the T2DM patients had CKD (urinary albumin creatinine ratio (UACR) ≥30 mg/g and/or estimated GFR [eGFR] <60 mL/min/1.73 m2). The renal dysfunction as per eGFR criteria (<60 mL/min/1.73 m2) was reported in about 23% while as per UACR criteria (≥30 mg/g) it was reported in about 35% patients.Conclusion:This interim analysis results suggests that over 40% of T2DM patients have CKD. Despite this high number of T2DM patients with CKD, eGFR analysis shows there are almost 80% of T2DM patients still have reasonably good renal function (eGFR above 60 ml/min), which ensures less restrictions in selecting oral anti-diabetic drugs. Full study results from Start-India study will provide detail insights into the occurrence of CKD in patients with T2DM in India.

Genetic etiology of type 2 diabetes mellitus: a review

Type 2 diabetes mellitus (T2DM) is the most common form of diabetes characterized by elevated levels of plasma glucose caused by impairment in both insulin secretion and action. It is becoming an epidemic leading to various complications and its prevalence and incidence are increasing at an alarming rate in developing countries like India, raising a major public health concern. Both the genetic and environmental factors play a strong role in the manifestation of this complex genetic disorder. In the recent years, there has been a spate of molecular genetic investigations, including whole genome scans, to test the association of genetic variants with T2DM in different patho-physiological pathways. A large number of candidate genes have been identified to be associated with T2DM, albeit only a couple of them show consistency in association in different populations/ethnic groups. Given relatively high risk for T2DM in India and immense genetic heterogeneity and substructure of the constituent populations, the number of studies is too small to be able to characterize the genetic basis of the disease in India. The recent dramatic increase in number of affected people indicates that lifestyle factors related to urbanization and sedentary occupations may be particularly important in triggering the genetic elements that cause this type of diabetes. Therefore, it is imperative to precisely establish the underlying genetic and environmental factors behind this complex genetic disorder so that preventive measures can be initiated. We have attempted to review the molecular genetic studies conducted, till date, globally on T2DM along with the epidemiological, environmental and ethnic factors implicated in the manifestation of T2DM.

A novel Gymnema sylvestre extract stimulates insulin secretion from human islets in vivo and in vitro

Many plant-based products have been suggested as potential antidiabetic agents, but few have been shown to be effective in treating the symptoms of Type 2 diabetes mellitus (T2DM) in human studies, and little is known of their mechanisms of action. Extracts of Gymnema sylvestre (GS) have been used for the treatment of T2DM in India for centuries. The effects of a novel high molecular weight GS extract, Om Santal Adivasi, (OSA(R)) on plasma insulin, C-peptide and glucose in a small cohort of patients with T2DM are reported here. Oral administration of OSA(R) (1 g/day, 60 days) induced significant increases in circulating insulin and C-peptide, which were associated with significant reductions in fasting and post-prandial blood glucose. In vitro measurements using isolated human islets of Langerhans demonstrated direct stimulatory effects of OSA(R) on insulin secretion from human ß-cells, consistent with an in vivo mode of action through enhancing insulin secretion. These in vivo and in vitro observations suggest that OSA(R) may provide a potential alternative therapy for the hyperglycemia associated with T2DM.

Role of adipocytokines in insulin resistance: Studies from Urban Western IndianPopulation

We determine the relative contribution adipocytokines to insulin resistance (IR) in urban Western Indian population. Theserum adipocytokine [leptin, adiponectin, resistin, tumor necrosis factor (TNF), and interleukin-6 (IL-6)] levels and theirassociation with IR in different metabolic disorders state like obesity and type 2 diabetes mellitus (T2DM) was determined. Atotal of 215 subjects including 41 control, 41 obese, 89 T2DM and 44 diabetic patients with hypertension were recruited inthis cross sectional study. Fasting adipocytokines and high sensitivity C Reactive Protein (hsCRP) levels were measured byELISA method. Insulin Resistance index of Homeostasis Model Assessment (HOMA-IR) was calculated. The relationbetween these variables was studied by Univariate and multiple logistic regression analysis. Adipocytokine profile wasaltered in insulin resistance state like obesity and T2DM compared to controls. Stepwise multiple linear regression analysiswith insulin resistance as a dependent variable shows that adiponectin as a significant predictor of insulin resistance in urbanWestern Indian population. Multiple logistic regression analysis using diabetes and obesity as the dependent variable revealedthat adipocytokines had a strong association with insulin resistance. This study provides a strong association betweenadipocytokine and IR. With the increasing epidemic of obesity and T2DM in India, these adipocytokine markers thatintegrate metabolic and inflammatory signals may play important roles in the early detection of diabetes and planning oftherapeutic strategies.