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

Diabetes Care. 2016 Oct;39(10):1760-7. doi: 10.2337/dc16-1241. Epub 2016 Aug 8.


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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Blood Glucose / metabolism
  • Body Mass Index
  • Diabetes Mellitus / epidemiology*
  • Diabetes Mellitus / prevention & control*
  • Diet
  • Female
  • Follow-Up Studies
  • Glucose Intolerance
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Incidence
  • India
  • Life Style*
  • Male
  • Metformin / therapeutic use
  • Middle Aged
  • Obesity / therapy
  • Overweight / therapy
  • Prediabetic State / epidemiology*
  • Prediabetic State / prevention & control*
  • Socioeconomic Factors
  • Whites


  • Blood Glucose
  • Glycated Hemoglobin A
  • Metformin