Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments lifestyle intervention, standard of care
Sponsor Emory University
Collaborator Madras Diabetes Research Foundation
Start date May 2009
End date July 2017
Trial size 599 participants
Trial identifier NCT01283308, IRB00016503, LT07-115

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(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.
standard of care
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.
(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.
lifestyle intervention
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.

Primary Outcomes

Measure
Diabetes Incidence
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)

Secondary Outcomes

Measure
Body Weight
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Cost-effectiveness
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Waist circumference
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Percent Body Fat
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Blood Pressure
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Glycosylated hemoglobin (HbA1c)
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Plasma Lipids
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Beta Cell Function
time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Dietary Intake
time frame: aseline through end of follow-up (mean follow-up time = 3 years)
Program Acceptability
time frame: Baseline through end of follow-up

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - Does not fulfill inclusion criteria - 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.

Additional Information

Official title The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
Principal investigator Viswanathan Mohan, MD, PhD
Description Aims: The Diabetes Community Lifestyle Improvement Program (D-CLIP) aims to implement and evaluate in a controlled, randomized trial the effectiveness, cost-effectiveness, and sustainability of a culturally appropriate, low-cost, and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India. Methods: D-CLIP, a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program, utilizes innovated methods (a step-wise model of diabetes prevention with lifestyle and metformin added when needed; inclusion of individuals with isolated impaired glucose tolerance, isolated impaired fasting glucose, and both; classes team-taught by professionals and trained community educators) with the goals of increasing diabetes prevention, community acceptability, and long-term dissemination and sustainability of the program. The primary outcome is, diabetes incidence, and secondary outcomes are cost-effectiveness, changes in anthropometric measures, plasma lipids, blood pressure, blood glucose, and HbA1c, and program acceptability and sustainability assessed using a mixed methods approach. Conclusion: D-CLIP, a low-cost, community-based, research program, addresses the key components of translational research and can be used as a model for prevention of chronic diseases in other low- and middle-income country settings.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Emory University.