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A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India (D-CLIP)

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ClinicalTrials.gov Identifier: NCT01283308
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : October 31, 2016
Sponsor:
Collaborator:
Madras Diabetes Research Foundation
Information provided by (Responsible Party):
Venkat Narayan, Emory University

Tracking Information
First Submitted Date  ICMJE January 24, 2011
First Posted Date  ICMJE January 25, 2011
Last Update Posted Date October 31, 2016
Study Start Date  ICMJE May 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2011)
Diabetes Incidence [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01283308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2011)
  • Body Weight [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    Weight will be measured in kilograms using a standardized, calibrated scale. Weight loss in kilograms and percent weight loss will be calculated.
  • Cost-effectiveness [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    The cost-effectiveness of the intensive lifestyle program, from the perspectives of a single payer system and society, will be compared with standard lifestyle advice by conducting incremental cost-effective analyses in which the net costs and net effectiveness of the intensive lifestyle program and the standard lifestyle advice is calculated and expressed as a ratio.
  • Waist circumference [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    Waist circumference in centimeters will be measured using a non-elastic tape measure. Change in waist circumference will be calculated.
  • Percent Body Fat [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    Percent body fat will be measured using bioelectrical impedance (Beurer machine).
  • Blood Pressure [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    Blood Pressure will be measured using standard procedures with an electronic BP apparatus.
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    HbA1c will be measured from a fasting venous blood sample.
  • Plasma Lipids [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    Plasma levels of high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, and total cholesterol will be measured from fasting venous blood samples.
  • Beta Cell Function [ Time Frame: Baseline through end of follow-up (mean follow-up time = 3 years) ]
    Changes in beta cell function [as measured by the Oral Disposition Index, calculated as (ΔI0-30 /ΔG0-30) x (1/fasting insulin)] and insulin resistance (using the Homeostasis Model Assessment of Insulin Resistance, HOMA-IR) will be calculated.
  • Dietary Intake [ Time Frame: aseline through end of follow-up (mean follow-up time = 3 years) ]
    Changes in average diet are assessed by comparing the results of a 12-month food frequency questionnaire (FFQ) from baseline to the end of the intervention period and during follow-up.
  • Program Acceptability [ Time Frame: Baseline through end of follow-up ]
    The acceptability of the intervention will be assessed through focus group discussions with participants who received the lifestyle intervention and phone interviews with program drop-outs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India
Official Title  ICMJE The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms
  • Active Comparator: Standard of Care
    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.
    Intervention: Behavioral: Standard of Care
  • Experimental: Lifestyle Intervention
    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.
    Intervention: Behavioral: Lifestyle Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2014)
599
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2011)
600
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01283308
Other Study ID Numbers  ICMJE IRB00016503
LT07-115 ( Other Identifier: Other )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Venkat Narayan, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Madras Diabetes Research Foundation
Investigators  ICMJE
Principal Investigator: Viswanathan Mohan, MD, PhD Madras Diabetes Research Foundation/Dr. Mohan's Diabetes Specialities Centre
Principal Investigator: K.M. Venkat Narayan, MD Emory University
PRS Account Emory University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP