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Author Notes:

Corresponding author: Mary Beth Weber, mbweber@emory.edu

M.B.W. was primary author of the manuscript and conducted some analysis.

H.R. oversaw data collection and participant management at the study site.

L.R.S. conducted the primary analysis.

M.B.W., H.R., K.M.V.N., and V.M. designed the trial.

M.B.W., H.R., and R.M.A. developed the lifestyle intervention curriculum.

All authors contributed to the manuscript discussion, provided edits to the text, and reviewed and approved the manuscript.

K.M.V.N. and V.M. are co-primary investigators of the study and provided senior leadership and direction to the team.

M.B.W. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

No potential conflicts of interest relevant to this article were reported.

Subject:

Research Funding:

This project is supported by a BRiDGES grant from the International Diabetes Federation (LT07-115).

BRiDGES, an International Diabetes Federation project, is supported by an educational grant from Lilly Diabetes.

Additional support was provided by the Global Health Institute at Emory University.

M.B.W. received funding from two National Institute of Diabetes and Digestive and Kidney Diseases T32 grants (5T3-2DK-007298-33 and T32-DK-007734-16).

L.R.S. received funding from the Human Health Molecules to Humankind program funded by the Burroughs Wellcome Fund grant BWF 1008188.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Endocrinology & Metabolism
  • IMPAIRED GLUCOSE-TOLERANCE
  • LIFE-STYLE INTERVENTION
  • BETA-CELL FUNCTION
  • INSULIN-RESISTANCE
  • FASTING GLUCOSE
  • ASIAN INDIANS
  • FOLLOW-UP
  • TYPE-2
  • RISK
  • ASSOCIATIONS

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

Tools:

Journal Title:

Diabetes Care

Volume:

Volume 39, Number 10

Publisher:

, Pages 1760-1767

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2016 by the American Diabetes Association.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NoDerivs-NonCommercial 1.0 Generic License (http://creativecommons.org/licenses/by-nc-nd/1.0/).

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