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Efficacy of Primary Prevention Interventions When Fasting And

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Efficacy of Primary Prevention Interventions When Fasting And Clinical Care/Education/Nutrition/Psychosocial Research ORIGINAL ARTICLE Efficacy of Primary Prevention Interventions When Fasting and Postglucose Dysglycemia Coexist Analysis of the Indian Diabetes Prevention Programmes (IDPP-1 and IDPP-2) AMBADY RAMACHANDRAN, MD ANANTH SAMITH SHETTY, MBBS, MDRC done among subjects with IGT in differ- NANDITHA ARUN, MD CHAMUKUTTAN SNEHALATHA, DSC ent ethnic populations (9–14). Among these, only the Diabetes Reduction As- sessment with Ramipril and Rosiglitazone OBJECTIVE — Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have Medication (DREAM) trial (12) recruited different pathophysiological abnormalities, and their combination may influence the effective- subjects with either isolated IFG (iIFG) or ness of the primary prevention tools. The hypothesis was tested in this analysis, which was done isolated IGT (iIGT) or both. Rosiglitazone in a pooled sample of two Indian Diabetes Prevention Programmes (IDPP-1 and IDPP-2). was found to be a potent agent in prevent- ing diabetes in this trial (12). The Diabe- RESEARCH DESIGN AND METHODS — Researchers analyzed and followed up on tes Prevention Programme (DPP) (9) the details of 845 of the 869 IGT subjects in the two studies for 3 years. Incidence of diabetes and recruited subjects with a fasting glucose reversal to normoglycemia (normal glucose tolerance [NGT]) were assessed in group 1 with baseline isolated IGT (iIGT) (n ϭ 667) and in group 2 with IGT ϩ IFG (n ϭ 178). The proportion in the range of 5.3–6.9 mmol/l (95–125 developing diabetes in the groups were analyzed in the control arm with standard advice mg/dl) and 2-h postglucose of 7.8–11 (IDPP-1) (n ϭ 125), lifestyle modification (LSM) (297 from both), metformin (n ϭ 125, IDPP-1), mmol/l (140–199 mg/dl) and nearly one- and LSM ϩ metformin (n ϭ 121, IDPP-1) and LSM ϩ pioglitazone (n ϭ 298, IDPP-2). Cox third of the participants had IFG by the regression analysis was used to assess the influence of IGT ϩ IFG versus iIGT on the effectiveness present criteria (15). of the interventions. Results of the Indian Diabetes Preven- tion Programme-1 (IDPP-1) showed that RESULTS — Group 2 had a higher proportion developing diabetes in 3 years (56.2 vs. 33.6% a moderate lifestyle modification (LSM) ϭ ϭ in group 1, P 0.000) and a lower rate of reversal to NGT (18 vs. 32.1%, P 0.000). Cox or a small dose of metformin (500 mg/ regression analysis showed that effectiveness of intervention was not different in the presence of day) reduced the risk of diabetes in a rel- fasting and postglucose glycemia after adjusting for confounding variables. atively nonobese but insulin resistant CONCLUSIONS — The effectiveness of primary prevention strategies appears to be similar Asian Indian population (13). In the in subjects with iIGT or with combined IGT ϩ IFG. However, the possibility remains that a larger IDPP-2 study, we noted that pioglitazone study might show that the effectiveness is lower in those with the combined abnormality. did not improve the efficacy of LSM in Asian Indians (14). In both studies, sub- Diabetes Care 33:2164–2168, 2010 jects with persistent IGT and fasting glu- cose levels below 6.9 mmol/l were mpaired glucose tolerance (IGT) and Analysis of six prospective studies recruited. Therefore, some participants impaired fasting glucose (IFG) have a among subjects with IGT showed that the also had IFG. In view of the higher degree I high potential to convert to type 2 dia- incidence of diabetes varied widely from of biochemical abnormalities occurring betes. While an elevated basal hepatic 23 to 62% within two to twenty-seven when fasting and postprandial dysglyce- glucose output and impaired early phase years of follow-up (3). The incidence was mia coexisted, it was considered impor- insulin secretion are the major abnormal- higher among populations with high tant to study whether the combined ities in IFG, IGT is characterized by more prevalence of diabetes than in white pop- abnormalities influenced the cumulative severe muscle insulin resistance (IR) and ulations. Incidence rates of diabetes in incidence of diabetes in comparison with defects in late insulin secretion (1). subjects with IFG or IGT or with a com- subjects with iIGT. To increase the sam- Among Asian Indians, higher degrees of bined abnormality were varied in differ- ple size, data from both IDPP studies were IR and ␤-cell dysfunction are seen in IFG ent populations (4–8). pooled. The participants’ baseline charac- than in IGT (2). Primary prevention studies have been teristics were identical in the two studies. ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● RESEARCH DESIGN AND From the India Diabetes Research Foundation and Dr. A. Ramachandran’s Diabetes Hospitals, Chennai, METHODS — IDPP-1 and IDPP-2 India. Corresponding author: Ambady Ramachandran, [email protected]. were 3-year prospective, randomized Received 25 June 2009 and accepted 26 May 2010. Published ahead of print at http://care.diabetesjournals. controlled studies among Asian Indian org on 2 June 2010. DOI: 10.2337/dc09-1150. subjects with persistent IGT (13,14). © 2010 by the American Diabetes Association. Readers may use this article as long as the work is properly IDPP-1 had four groups: 1) control with cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons. standard advice, 2) LSM, 3) treated with org/licenses/by-nc-nd/3.0/ for details. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby metformin (500 mg/day), and 4) a com- marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. bination of LSM and metformin (13). 2164 DIABETES CARE, VOLUME 33, NUMBER 10, OCTOBER 2010 care.diabetesjournals.org Ramachandran and Associates Figure 1—The selection of original cohorts for the two studies, randomization, and the final outcome in the available subjects at the 3rd-year follow-up are shown. The selection criteria for this analysis and the baseline distribution of subjects in group 1 (iIGT) and group 2 (IGT ϩ IFG) are also shown. IDPP-2 was done in a different cohort of (28.5% with LSM, 26.4% with met- (2-h plasma glucose 7.8–11.0 mmol/l, IGT subjects using LSM and placebo as formin, and 28.2% with LSM and met- 140–199 mg/dl) and group 2 as those the control group and LSM and pioglita- formin) when compared with the control with combined IFG (fasting 6.1–6.9 zone (30 mg/day) as the intervention group (13). In IDPP-2, the cumulative in- mmol/l, 110–125 mg/dl) and IGT. Data group (14). cidences of diabetes at 36 months were were available for 667 subjects in group 1 Sample selection for this analysis is similar in the intervention (29.8%) and and 178 subjects in group 2 (Fig. 1). shown in the flow chart in Figure 1 (Fig. placebo groups (31.6%) (14). In this study, the group with standard 1). The two-stage selection procedure was BMI, waist circumference, and blood care from IDPP-1 was defined as the con- used for recruiting reproducible IGT pressure were measured at baseline and trol group. The LSM group included LSM only. No case of isolated IFG was selected, during each review. Plasma glucose was from IDPP-1 and the placebo group from and the presence of IFG was not an inclu- measured (glucose oxidase method) at IDPP-2. The effect of LSM ϩ drugs (met- sion criterion. fasting, 30 min, and 2 h during the formin and pioglitazone) was analyzed In both studies the primary outcome OGTT, and corresponding plasma insulin since the numbers with IGT ϩ IFG were was the development of diabetes detected was measured using the radioimmunoas- small in the individual drug group, and by a standard oral glucose tolerance test say kit of DiaSorin (Saluggia, Italy). In- the outcome measures were present in (OGTT) (fasting plasma glucose Ն7.0 dexes of insulin resistance (homeostasis numbers inadequate for statistical mmol/l and/or 2-h post glucose Ն11.1 model assessment of insulin resistance comparisons. mmol/l) (15). Reversal to normal glucose [HOMA-IR]) (16) and early insulin secre- tolerance (fasting plasma glucose Ͻ6.1 tion [(30-min fasting insulin [pmol/l]) Ϭ Statistical analysis mmol/l and 2-h plasma glucose tolerance 30-min glucose (mmol/l) (index of insu- Means and SD are shown for normally Ͻ7.8 mmol/l) was also considered as an lin secretion [␦ I/G])] were calculated distributed variables. Student t test was outcome. All subjects underwent annual (17). Subjects from both studies having used for intergroup comparison. Median OGTT. A semiannual postprandial capil- all the above measurements were in- values were used for skewed variables, lary glucose test was done. Diabetes de- cluded for this analysis. Among the total and Mann-Whitney U test was used for tected in any person was confirmed with of 869 followed up for 3 years in both the comparisons. Intergroup proportions an OGTT. studies, data on plasma insulin was not were compared using the ␹2 test. Kaplan- In IDPP-1, in a median follow-up of available for 24 subjects. Hence this anal- Meier survival analysis was used to cal- 30 months, the relative risk reductions ysis was done using the data of 845 sub- culate the probability of cumulative with the interventions were similar jects. Group 1 was defined as having iIGT incidence of diabetes in the groups. Log- care.diabetesjournals.org DIABETES CARE, VOLUME 33, NUMBER 10, OCTOBER 2010 2165 Diabetes prevention in combined IGT and IFG -Table 1—Comparison of characteristics of study subjects with iIGT (group 1) and IGT ؉ IFG reversal to normal glucose tolerance in re (group 2) lation to the control group (P ϭ 0.000).
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