Ammar Raza

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.

Prevalence of dyslipidemia in adult Indian diabetic patients: A cross sectional study (SOLID)

Context: India leads the world with largest number of diabetic patients and is often referred to as the diabetes capital of the world. Diabetic dyslipidemia in India is one of the main cause for Coronary Artery Disease (CAD) mortality. Although diabetes continues to be a major lifestyle condition in India, there is a lack of studies in India on whether dyslipidemia in Indian diabetics is being adequately controlled. Our study provides critical insights into the insights into proportion of diabetes patients achieving lipid goal in India. Aims: The primary objective of our study was to assess the control of dyslipidemia in the Indian diabetic population treated with lipid lowering drugs (LLDs), as per American Diabetes Association (ADA) 2010 guidelines. Settings and Design: The study was carried out in a real world Indian clinical setting involving 178 sites. This is a multicenter, noninterventional, and cross-sectional observational study. Materials and Methods: A total of 5400 adult subjects with established type-2 diabetes mellitus (T2DM) and dyslipidemia were recruited for the study. Patients in the study were on LLD at a stable dose for at least last 3 months before the designated study visit. Routine lipid profile tests were conducted for all patients. Statistical Analysis Used: Descriptive statistics was used to analyze qualitative and discrete variables. Chi-square test and t-test were conducted to assess the existence of statistically significant association between the variables. Results: A total of 5400 patients with T2DM from 178 centers across India were recruited. Out of the total population, 56.75% (N = 3065) of them were males. Primary end-point of low-density lipoprotein cholesterol (LDL-C) level below ADA 2010 target was achieved in a total of 48.74% (N = 2632) patients. Gender was significantly associated with lipid levels and age was significantly (P < 0.05) correlated with all lipid levels. Control rates of other lipid parameters like high-density lipoprotein cholesterol, triglyceride, and total cholesterol in the study were 60.48% (N = 3236), 57.54% (N = 3107), and 92.24% (N = 4981) respectively. Among those with overt cardiovascular disease (CVD), target LDL-C level of < 70 mg/dL was achieved in 22.87% (70 out of 306) patients. The LDL-C levels of 49.03% (N = 1768) patients who were on statin therapy were within target levels, while 53.46% (N = 634) patients who were on statin and their combinations with other LLDs had their LDL-C levels within the stipulated range. Conclusions: This study has reveled that dyslipidemia control in Indian T2DM patients is very poor with almost half of them not reaching their LDL -C goal. Dyslipidemia being one of the main risk factors for CVD in T2DM patients there is a need to treat dyslipidemia aggressively to reduce risk of future CV events.

Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Mellitus Patients: START-India Study

Objective: Despite rising incidence of diabetes in India, we currently lack country wide data on the prevalence of CKD in T2DM patients. Hence this nationwide study was planned. Methods: This was a nationwide, cross-sectional, observational, multi-centric study to assess prevalence of CKD among T2DM patients. The primary endpoint of the study was to estimate proportion of T2DM patients with CKD (glomerular filtration rate [GFR] <60 ml/min/1.73 m2or albumin creatinine ratio [ACR] ≥ 30 mg/g or ≥ 3 mg/mmol or both). The blood/plasma and urine samples, were collected for estimation of hemoglobin A1c, microalbuminuria, serum creatinine, urine creatinine, and routine urine analysis. Results: Of the 3043 screened subjects, 3000 eligible subjects were enrolled, out of which 46% were females. The mean age was 53.4 (± 11.9) years, with a mean body mass index of 27.3 (± 4.8) kg/m2. Both micro and macro vascular complications were reported. In the studied population with T2DM, 47.8% had mildly decreased, 15.1% had mild to moderately decreased, and 1.8% had severely decreased GFR respectively. As per ACR categorization, 61.3% had normal to mildly increased ACR, 25.6% with moderately increased and 7.2% with severely increased ACR were seen. We observed a significant (p<0.0001) weak negative correlation (-0.23069) between eGFR< 60 mL/ min/1.73 m² and urinary ACR in over six hundred patients. We found 48.4% prevalence of CKD in T2DM patients. The results on analysis of HbA1c goal achievement showed that the patients without CKD had a better success rate to achieve the target <7% goal of HbA1c compared to those who had CKD (29.6% vs. 23.4%). Conclusion: Study reported higher prevalence of CKD which was driven by the ACR levels and majority of the patients had reasonable eGFR. This can be a guide to select drug and dosage of diabetes drug as it depends on kidney function.

A Study to derive distribution of carotid intima media thickness and to determine its COrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population (SCORE-India)

Background There is presently no data to describe normal distribution of carotid intima-media thickness (CIMT), an established measure of subclinical atherosclerosis, in Indian subjects. Methods In this multi-centric study, 1229 subjects with age ≥30 years and no previous cardiovascular disease (CVD) underwent CVD risk factor assessment and CIMT measurement. Mean far wall common carotid artery IMT was measured on both sides and averaged. Results Mean age of the subjects was 48.0 ± 12.0 years and 54.2% were men. CIMT measurement was feasible in 1157 subjects. Mean, median and 75th percentile values of CIMT for different age-groups were derived for men and women separately. There was a progressive increase in CIMT with increasing age (P < 0.001) and men had higher CIMT values than women (0.608 ± 0.12 mm vs. 0.579 ± 0.11 mm, P < 0.001). The CIMT values were also higher in diabetics (0.635 ± 0.10 mm) and hypertensives (0.624 ± 0.10 mm) as compared to non-diabetics (0.589 ± 0.12 mm, P < 0.001) and non-hypertensives (0.592 ± 0.12, P 0.02) respectively. Among continuous variables, age, systolic blood pressure and fasting blood glucose had strong to modest correlation with CIMT (Pearsons r 0.524, 0.282 and 0.192 respectively, all P values <0.001), whereas body mass index, diastolic blood pressure and serum triglycerides exhibited weak but still statistically significant relationship (Pearsons r 0.069, P 0.019; Pearsons r 0.065, P 0.026; and Pearsons r 0.094, P 0.001, respectively). Conclusions This is the first study to provide age- and gender-specific distribution of CIMT in Indian subjects free from CVD. This information should help facilitate further research and clinical work involving CIMT in India.