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

Mary Beth Weber, Harish Ranjani, Lisa R Staimez, Ranjit M Anjana, Mohammed K Ali, K M Venkat Narayan, Viswanathan Mohan, Mary Beth Weber, Harish Ranjani, Lisa R Staimez, Ranjit M Anjana, Mohammed K Ali, K M Venkat Narayan, Viswanathan Mohan

Abstract

Objective: This 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 methods: The 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.

Results: During 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%).

Conclusions: Stepwise 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.

© 2016 by the American Diabetes Association.

Figures

Figure 1
Figure 1
D-CLIP trial profile.
Figure 2
Figure 2
Cumulative incidence of diabetes by study arm in the D-CLIP trial from baseline to year 3.

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