[Show abstract][Hide abstract]ABSTRACT: The Indian Diabetes Prevention Programme-1 (IDPP-1) showed that lifestyle modification (LSM) and metformin were effective for primary prevention of diabetes in subjects with impaired glucose tolerance (IGT). Among subjects followed up for 3 years (n = 502), risk reductions versus those for the control group were 28.5, 26.4, and 28.2% in LSM, metformin (MET), and LSM plus MET groups, respectively. In this analysis, the roles of changes in secretion and action of insulin in improving the outcome were studied.
For this analysis, 437 subjects (93 subjects with normoglycemia [NGT], 150 subjects with IGT, and 194 subjects with diabetes) were included. Measurements of anthropometry, plasma glucose, and plasma insulin at baseline and at follow-up were available for all of them. Indexes of insulin resistance (homeostasis model assessment of insulin resistance) and beta-cell function (insulinogenic index [DeltaI/G]: 30-min fasting insulin divided by 30-min glucose) were also analyzed in relation to the outcome.
Subjects with IGT showed a deterioration in beta-cell function with time. Individuals with higher insulin resistance and/or low beta-cell function at baseline had poor outcome on follow-up. In relation to no abnormalities, the highest incidence of diabetes occurred when both abnormalities coexisted (54.9 vs. 33.7%, chi(2) = 7.53, P = 0.006). Individuals having abnormal insulin resistance (41.1%) or abnormal DeltaI/G (51.2%, chi(2) = 4.87, P = 0.027 vs. no abnormalities) had lower incidence. Normal beta-cell function with improved insulin sensitivity facilitated reversal to NGT, whereas deterioration in both resulted in diabetes. The beneficial changes were better with intervention than in the control group. Intervention groups had higher rates of NGT and lower rates of diabetes.
In the IDPP-1 subjects, beneficial outcomes occurred because of improved insulin action and sensitivity caused by the intervention strategies.
[Show abstract][Hide abstract]ABSTRACT: The objective of this prevention programme was to study whether combining pioglitazone with lifestyle modification would enhance the efficacy of lifestyle modification in preventing type 2 diabetes in Asian Indians with impaired glucose tolerance.
In a community-based, placebo-controlled 3 year prospective study, 407 participants with impaired glucose tolerance (mean age 45.3 +/- 6.2 years, mean BMI 25.9 +/- 3.3 kg/m(2)) were sequentially grouped to receive either: lifestyle modification plus pioglitazone, 30 mg (n = 204) or lifestyle modification plus placebo (n = 203). The participants and investigators were blinded to the assignment. The primary outcome was development of diabetes.
At baseline, both groups had similar demographic, anthropometric and biochemical characteristics. At year 3, the response rate was 90.2%. The cumulative incidence of diabetes was 29.8% with pioglitazone and 31.6% with placebo (unadjusted HR 1.084 [95% CI 0.753-1.560], p = 0.665). Normoglycaemia was achieved in 40.9% and 32.3% of participants receiving pioglitazone and placebo, respectively (p = 0.109). In pioglitazone group, two deaths and two non-fatal hospitalisations occurred due to cardiac problems; in the placebo group there were two occurrences of cardiac disease.
Despite good adherence to lifestyle modification and drug therapy, no additional effect of pioglitazone was seen above that achieved with placebo. The effectiveness of the intervention in both groups was comparable with that of lifestyle modification alone, as reported from the Indian Diabetes Prevention Programme-1. The results are at variance with studies that showed significant relative risk reduction in conversion to diabetes with pioglitazone in Americans with IGT. An ethnicity-related difference in the action of pioglitazone in non-diabetic participants may be one explanation.
ClinicalTrials.gov NCT00276497 Funding: This study was funded by the India Diabetes Research Foundation.
[Show abstract][Hide abstract]ABSTRACT: To analyse and compare the clinical profile and glycaemic outcome in known diabetic cases in South Indian urban and periurban populations.
Details of known type 2 diabetic cases identified in a population survey of diabetes in Chennai city, Kanchipuram town and Periurban Villages (PUV) of Panruti in Tamil Nadu were analyzed (n=524, M:F, 256:268). Glycaemic outcome, prevalence of hypertension, dyslipidaemia and obesity, and treatment details were studied and compared between the areas.
Mean age at diagnosis was 45.3 +/- 10.1 years, prevalence of hypertension was 57.4% (32% known), 48% were obese and a larger percentage (63.3%) had abdominal obesity Dyslipidaemia was present in nearly 50%. Abnormalities were more in urban areas than in PUV. Glycaemic target (post prandial glucose < or =160 mg/dl) was met by 28.8% only; better results were seen in PUV. In PUV 46% were not taking any diabetic treatment. As expected, majority of patients in all areas were treated with oral drugs.
This population-based data indicated that the clinical outcome in known diabetic cases was far from satisfactory even in the city, where specialized diabetes care was available.
Full-text · Article · Jul 2008 · The Journal of the Association of Physicians of India
[Show abstract][Hide abstract]ABSTRACT: To compare prevalence of diabetes, impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and cardiovascular risk factors between a city, a town, and periurban villages (PUVs) in southern India and to look for temporal changes in the city and PUVs.
Subjects aged >/=20 years were studied in Tamilnadu, India, in Chennai (city, n = 2,192; 1,053 men and 1,138 women), Kanchipuram (town, n = 2,290; 988 men and 1,302 women), and Panruti (PUVs, n = 2,584; 1,280 men and 1,304 women) in 2006. Demographic, socioeconomic, and anthropometric details; blood pressure; physical activity; diet habits; and lipids were studied. Risk associations with diabetes were analyzed using multiple logistic regression analyses. Present and previous data in the city and the PUVs were compared.
Mean BMI, waist circumference, and family history of diabetes were significantly lower in the PUVs. The PUVs had a lower prevalence of diabetes (9.2 [95% CI 8.0-10.5], P < 0.0001) than the city (18.6 [16.6-20.5]) and town (16.4 [14.1-18.6]). Approximately 40% of subjects were newly diagnosed. Prevalence of impaired glucose tolerance (IGT) was higher (P < 0.0001) in the city (7.4 [6.2-8.5]) than in the town (4.3 [3.3-5.3]) and the PUVs (5.5 [4.6-6.5]). Prevalence of IFG was generally low. Age, family history, and waist circumference were significantly associated with diabetes, while physical activity was not. Overweight, elevated waist circumference, hypertension, and dyslipidemia were more prevalent in the city.
In the city, diabetes increased from 13.9 to 18.6% in 6 years and IGT decreased significantly. The town and city had similar prevalences; the PUVs had lower diabetes prevalence, but prevalence had increased compared with that in a previous survey. Cardiometabolic abnormalities were more prevalent in urban populations.
[Show abstract][Hide abstract]ABSTRACT: In subjects with impaired glucose tolerance (IGT) who participated in the Indian Diabetes Prevention Programme (IDPP), abnormalities related to body mass index, waist circumference (WC), blood pressure (BP), lipid profile and electrocardiography were analysed (at baseline and third-year follow-up) in control, lifestyle modification (LSM), metformin (MET) and LSM + MET groups. At baseline, elevated levels of low-density lipoprotein cholesterol (LDL-C) showed the highest (78.6%) and total cholesterol (TC) showed the lowest (42%) prevalence. At follow-up, prevalence of hypertension (BP > or = 130/> or = 85 mmHg) had increased significantly in all groups. Cardiovascular abnormalities were lower in intervention groups, with the lowest rates in the MET group (p=0.013 vs. control); the LDL-C level decreased in intervention groups. In this programme, Asian Indian IGT subjects were observed to have a high prevalence of cardiovascular risk factors. LSM and MET had beneficial effects on the atherogenic phenotype of lipids but had no influence on blood pressure.
Full-text · Article · Mar 2008 · Diabetes & Vascular Disease Research
[Show abstract][Hide abstract]ABSTRACT: In the Indian Diabetes Prevention Programme (IDPP), a 3-year randomized, controlled trial, lifestyle modification (LSM) and metformin helped to prevent type 2 diabetes in subjects with impaired glucose tolerance (IGT). The direct medical costs and cost-effectiveness of the interventions relative to the control group are reported here.
Relative effectiveness and costs of interventions (LSM, metformin, and LSM and metformin) in the IDPP were estimated from the health care system perspective. Costs of intervention considered were only the direct medical costs. Direct nonmedical, indirect, and research costs were excluded. The cost-effectiveness of interventions was measured as the amount spent to prevent one case of diabetes within the 3-year trial period.
The direct medical cost to identify one subject with IGT was Indian rupees (INR) 5,278 ($117). Direct medical costs of interventions over the 3-year trial period were INR 2,739 ($61) per subject in the control group, INR 10,136 ($225) with LSM, INR 9,881 ($220) with metformin, and INR 12,144 ($270) with LSM and metformin. The number of individuals needed to treat to prevent a case of diabetes was 6.4 with LSM, 6.9 with metformin, and 6.5 with LSM and metformin. Cost-effectiveness to prevent one case of diabetes with LSM was INR 47,341 ($1,052), with metformin INR 49,280 ($1,095), and with LSM and metformin INR 61,133 ($1,359).
Both LSM and metformin were cost-effective interventions for preventing diabetes among high risk-individuals in India and perhaps may be useful in other developing countries as well. The long-term cost-effectiveness of the interventions needs to be assessed.
[Show abstract][Hide abstract]ABSTRACT: Lifestyle modification helps in the primary prevention of diabetes in multiethnic American, Finnish and Chinese populations. In a prospective community-based study, we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger, leaner and more insulin resistant than the above populations.
We randomised 531 (421 men 110 women) subjects with IGT (mean age 45.9+/-5.7 years, BMI 25.8+/-3.5 kg/m(2)) into four groups. Group 1 was the control, Group 2 was given advice on lifestyle modification (LSM), Group 3 was treated with metformin (MET) and Group 4 was given LSM plus MET. The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria.
The median follow-up period was 30 months, and the 3-year cumulative incidences of diabetes were 55.0%, 39.3%, 40.5% and 39.5% in Groups 1-4, respectively. The relative risk reduction was 28.5% with LSM (95% CI 20.5-37.3, p=0.018), 26.4% with MET (95% CI 19.1-35.1, p=0.029) and 28.2% with LSM + MET (95% CI 20.3-37.0, p=0.022), as compared with the control group. The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM, 6.9 for MET and 6.5 for LSM + MET.
Progression of IGT to diabetes is high in native Asian Indians. Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT; there was no added benefit from combining them.
[Show abstract][Hide abstract]ABSTRACT: The rural Indian population is undergoing lifestyle transition due to socio-economic growth. This study was done to determine the temporal changes in prevalence of diabetes and IGT that could have occurred in a rural population in India as a result of the lifestyle transition.
A cross-sectional study of 1213 Asian-Indian subjects aged 20 years or over was done to look for the prevalence of diabetes and IGT using the 1999 WHO criteria. The temporal changes were assessed in comparison with a similar study conducted 14 years previously. The factors associated with the temporal changes were also analysed.
Nearly a three-fold increase in age- and sex-adjusted prevalence of diabetes (from 2.20% to 6.36%) was seen in 2003 when compared with a similar study done 14 years before. Prevalence of IGT did not change significantly (7.44% in 1989 vs 7.18% in 2003). Improvement in living conditions had occurred during the period, occupational changes were seen, the number of manual labourers had decreased and economic conditions had improved. BMI and waist circumference had increased. After correcting for age, sex and differences in time periods, waist circumference and physical inactivity showed significant associations with the increased prevalence of diabetes.
Demographic transition due to improved living conditions in rural India was associated with a three-fold increase in the prevalence of diabetes. Increased upper body adiposity and physical inactivity showed significant association with this phenomenon.