The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial

Abstract

OBJECTIVEThis study tests the effectiveness of expert guidelines for diabetes prevention: lifestyle intervention with addition of metformin, when required, among people with prediabetes.RESEARCH DESIGN AND METHODSThe Diabetes Community Lifestyle Improvement Program (D-CLIP) is a randomized, controlled, translation trial of 578 overweight/obese Asian Indian adults with isolated impaired glucose tolerance (iIGT), isolated impaired fasting glucose (iIFG), or IFG+IGT in Chennai, India. Eligible individuals were identified through community-based recruitment and randomized to standard lifestyle advice (control) or a 6-month, culturally tailored, U.S. Diabetes Prevention Program–based lifestyle curriculum plus stepwise addition of metformin (500 mg, twice daily) for participants at highest risk of conversion to diabetes at ≥4 months of follow-up. The primary outcome, diabetes incidence, was assessed biannually and compared across study arms using an intention-to-treat analysis.RESULTSDuring 3 years of follow-up, 34.9% of control and 25.7% of intervention participants developed diabetes (P = 0.014); the relative risk reduction (RRR) was 32% (95% CI 7–50), and the number needed to treat to prevent one case of diabetes was 9.8. The RRR varied by prediabetes type (IFG+IGT, 36%; iIGT, 31%; iIFG, 12%; P = 0.77) and was stronger in participants 50 years or older, male, or obese. Most participants (72.0%) required metformin in addition to lifestyle, although there was variability by prediabetes type (iIFG, 76.5%; IFG+IGT, 83.0%; iIGT, 51.3%).CONCLUSIONSStepwise diabetes prevention in people with prediabetes can effectively reduce diabetes incidence by a third in community settings; however, people with iIFG may require different interventions.

Built Environment, Physical Activity and Diabetes

“…It has been shown that PA may prevent or delay the onset of T2DM through favourable effects on body weight, insulin sensitivity, glycaemic control, lipid profile, fibrinolysis, blood pressure, endothelial function and inflammatory defence systems 65 . Large randomized clinical trials provide evidence that supervized exercise programmes, with or without dietary modifications, play a significant role in the prevention of diabetes and other NCDs [66][67][68][69][70][71][72] . In India, a few trials have been conducted to assess the benefits of PA in T2DM 72,73 .…”

“…Large randomized clinical trials provide evidence that supervized exercise programmes, with or without dietary modifications, play a significant role in the prevention of diabetes and other NCDs [66][67][68][69][70][71][72] . In India, a few trials have been conducted to assess the benefits of PA in T2DM 72,73 . Recently, the Diabetes Community Lifestyle Improvement Program (D-CLIP), a randomized, controlled, translation trial of 578 overweight/obese Asian Indian adults with prediabetes (impaired glucose tolerance or impaired fasting glucose, or both) compared standard care to a culturally tailored lifestyle education curriculum based on the US DPP, plus stepwise addition of metformin (500 mg, twice daily).…”

“…During three years of follow-up, 34.9% in the control group and 25.7% in the intervention group developed diabetes; the relative reduction in diabetes incidence was 32%, and the number needed to treat to prevent one case of diabetes with the D-CLIP intervention was 9.8 (ref. 72). Table 2 provides evidence for exercise and prevention of diabetes [66][67][68][69][70][71][72] .…”

“…72). Table 2 provides evidence for exercise and prevention of diabetes [66][67][68][69][70][71][72] . Evidence also exists that interventions applied to people with impaired glucose tolerance are cost-effective and can reduce diabetes complications, such as cardiovascular mortality and retinopathy, and can also improve the quality of life 73 .…”

Diabetes: Leveraging the Tipping Point of the Diabetes Pandemic

“…NHS England launched a first-in-the-world national primary prevention program in 2016 (17), and the U.S. has made promising progress in determining diabetes trends (18). The next big challenge is to translate evidence into interventional programs at the population level in the most populous developing countries such as China and India (19). The spark of diabetes starts with friction between natural predisposition and nurtured challenges; the lasting rushing winds of insulin resistance fan the flames of the b-cell to burn out.…”