A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India

NCT01283308 | Completed

• 2 other identifiers: IRB00016503LT07-115
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 1

Brief Summary

People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; India; Prevention & Control; Lifestyle Intervention; Translational Research

Outcome Measures

Primary Outcomes (1)

• Diabetes Incidence

  At baseline and follow-up visit(s), a 75-g oral glucose tolerance test will be administered to measure both 2-hour post-load glucose (2HG) and fasting plasma glucose (FPG). After the intervention and maintenance periods, blood glucose will be measured by a FPG test. Diabetes is diagnosed by a FPG≥126 mg/dL or a 2HG≥200 mg/dL. Diabetes incidence will be calculated by determining the proportion of individuals progressing from pre-diabetes to diabetes at each time point.

  Baseline through end of follow-up (mean follow-up time = 3 years)

Secondary Outcomes (10)

• Body Weight

  Baseline through end of follow-up (mean follow-up time = 3 years)

• Cost-effectiveness

  Baseline through end of follow-up (mean follow-up time = 3 years)

• Waist circumference

  Baseline through end of follow-up (mean follow-up time = 3 years)

• Percent Body Fat

  Baseline through end of follow-up (mean follow-up time = 3 years)

• Blood Pressure

  Baseline through end of follow-up (mean follow-up time = 3 years)

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Participants randomized to the standard of care group will receive standard lifestyle advice for diabetes prevention consistent with expert recommendations for a healthy lifestyle, including losing 5-10% of their excess body weight, following standard dietary recommendations to reduce calorie and fat intake, and exercising at least 150 minutes per week.

Behavioral: Standard of Care

Lifestyle Intervention

EXPERIMENTAL

Intervention arm participants will participate in a step-wise model of diabetes prevention with the goal of reducing diabetes risk, primarily through (1) a weight loss of at least 7% and (2) 150 minutes or more per week of moderate level physical activity.

Behavioral: Lifestyle Intervention

Interventions

Lifestyle Intervention BEHAVIORAL

Intervention arm participants will attend 6 months of weekly classes where they will be taught the skills necessary to reach these goals. The curriculum for the classes is based on the DPP lesson plans. Social support will be provided by trained lay health educators and peer support groups. Participants who remain at highest risk of T2DM after four or more months in the program will be prescribed metformin in addition to continuing the lifestyle program. Metformin dosages will start at 500 mg per day, and, when appropriate, will increase to 1000 mg per day (given as 500 mg twice per day). This group will be comprised of individuals who have (1) Fasting plasma glucose values of 100 mg/dl or more and (2) elevated fasting HbA1c measures of 5.7% or more.

Lifestyle Intervention

Standard of Care BEHAVIORAL

Participants randomized to the standard of care group will meet with a physician and a dietician, attend one class/awareness lecture on diabetes prevention through weight loss and diet change and one class on exercise, and receive handouts reinforcing what they learn in class and with the dietician, fitness consultant, and physician.

Standard of Care

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live in or near Chennai, India
• Aged 20-65 years
• A BMI \>22 kg/m2 and/or a waist circumference \>90 cm for men and \>80 cm for women
• No prior diabetes diagnosis, except for gestational diabetes
• At high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 110 (measured during screening) AND Baseline fasting glucose of 100-125 mg/dL and/or 2-hour post-load glucose of 140-199 mg/dL
• Willingness to consent to randomization

You may not qualify if:

• Currently pregnant or breastfeeding
• History of or biomarkers indicating heart disease, serious illness, cancer diagnosis in the past 5 years, or other conditions that may impede or prohibit participation in an unsupervised diet change and physical activity program.

Sponsors & Collaborators

• Emory University: lead
• Madras Diabetes Research Foundation: collaborator

Study Sites (1)

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, 600 086, India

Location

Related Publications (9)

• Weber MB, Ranjani H, Anjana RM, Mohan V, Narayan KM, Gazmararian JA. Behavioral and psychosocial correlates of adiposity and healthy lifestyle in Asian Indians. Prim Care Diabetes. 2015 Dec;9(6):418-25. doi: 10.1016/j.pcd.2015.01.012. Epub 2015 Feb 26.

  PMID: 25733342 BACKGROUND

• Staimez LR, Weber MB, Ranjani H, Ali MK, Echouffo-Tcheugui JB, Phillips LS, Mohan V, Narayan KM. Evidence of reduced beta-cell function in Asian Indians with mild dysglycemia. Diabetes Care. 2013 Sep;36(9):2772-8. doi: 10.2337/dc12-2290. Epub 2013 Apr 17.

  PMID: 23596180 BACKGROUND

• Weber MB, Ranjani H, Meyers GC, Mohan V, Narayan KM. A model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. Prim Care Diabetes. 2012 Apr;6(1):3-9. doi: 10.1016/j.pcd.2011.04.005. Epub 2011 May 26.

  PMID: 21616737 BACKGROUND

• Ranjani H, Weber MB, Anjana RM, Lakshmi N, Narayan KMV, Mohan V. Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Diabetes Res Clin Pract. 2015 Oct;110(1):51-59. doi: 10.1016/j.diabres.2015.07.013. Epub 2015 Aug 13.

  PMID: 26321102 BACKGROUND

• Anjana RM, Ranjani H, Unnikrishnan R, Weber MB, Mohan V, Narayan KM. Exercise patterns and behaviour in Asian Indians: data from the baseline survey of the Diabetes Community Lifestyle Improvement Program (D-CLIP). Diabetes Res Clin Pract. 2015 Jan;107(1):77-84. doi: 10.1016/j.diabres.2014.09.053. Epub 2014 Oct 7.

  PMID: 25458336 BACKGROUND

• Weber MB, Ranjani H, Staimez LR, Anjana RM, Ali MK, Narayan KM, Mohan V. 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.

  PMID: 27504014 RESULT

• Pyo E, Weber MB, Sivaram J, Staimez LR, Mohan V, Anjana RM, Haardorfer R, Ranjani H. Construct validity of the 12-item Short Form Health Survey (SF-12) version 2 and the impact of lifestyle modifications on the health-related quality of life among Indian adults with prediabetes: results from the D-CLIP trial. Qual Life Res. 2024 Jun;33(6):1593-1603. doi: 10.1007/s11136-024-03648-6. Epub 2024 Apr 12.

  PMID: 38607494 DERIVED

• Ford CN, Weber MB, Staimez LR, Anjana RM, Lakshmi K, Mohan V, Narayan KMV, Harish R. Dietary changes in a diabetes prevention intervention among people with prediabetes: the Diabetes Community Lifestyle Improvement Program trial. Acta Diabetol. 2019 Feb;56(2):197-209. doi: 10.1007/s00592-018-1249-1. Epub 2018 Nov 13.

  PMID: 30426214 DERIVED

• Cioffi CE, Ranjani H, Staimez LR, Anjana RM, Mohan V, Weber MB. Self-efficacy and diabetes prevention in overweight South Asians with pre-diabetes. BMJ Open Diabetes Res Care. 2018 Oct 15;6(1):e000561. doi: 10.1136/bmjdrc-2018-000561. eCollection 2018.

  PMID: 30397491 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Viswanathan Mohan, MD, PhD

  Madras Diabetes Research Foundation/Dr. Mohan's Diabetes Specialities Centre

  PRINCIPAL INVESTIGATOR

• K.M. Venkat Narayan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hubert Professor of Global Health and Epidemiology

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: May 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

IN (1)