- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279240
Life Style Modifications Prevents Type 2 Diabetes in Asian Indians
The Indian Diabetes Prevention Programme Shows That Lifestyle Modification and Metformin Prevent Type 2 Diabetes in Asian Indian Subjects With Impaired Glucose Tolerance (IDPP1)
Study Overview
Detailed Description
Lifestyle modification helps in primary prevention of diabetes in multiethnic Americans, Finnish and Chinese populations. In a prospective community based study, we tested if the conversion to diabetes could be influenced by interventions in native Asian Indians with impaired glucose tolerance (IGT) who were younger, leaner and more insulin resistant than the above populations.
We randomized 531 (Men : Women, 421 : 110) subjects with IGT [mean age of 45.9 + 5.7 years and body mass index (BMI) of 25.8 + 3.5 kg/m2 into four groups. Group 1 was the control (CON), Group 2 was advised lifestyle modification (LSM), Group 3 was treated with metformin (MET) and Group 4 with LSM plus MET. Primary outcome measure was type 2 diabetes diagnosed by the WHO criteria.
In a median follow up of 30 months, three year cumulative incidence of diabetes were 55.0%, 39.3%, 40.5% and 39.5% in group 1 to 4 respectively. The relative risk reduction was 28.5% with LSM (95 % confidence interval (CI), (20.5 - 37.3), (p=0.018), 26.4% with MET (95% CI, 19.1 - 35.1) (p = 0.029) and 28.2% with LSM plus MET (95% CI, 20.3 - 37.0), (P=0.022) versus control group. The numbers needed to treat to prevent one incident case of diabetes were 6.4 for LSM, 6.9 for MET and 6.5 for LSM+MET.
Conversion of IGT to diabetes is high in native Asian Indians. LSM and metformin significantly reduced the incidence of diabetes in Asian Indians with IGT. There was no added benefit by combining both.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Tamilnadu
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Chennai, Tamilnadu, India, 600013
- Diabetes Research Centre & MV Hospital for Diabetes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both male and female. 35 - 55 years. No Known history of diabetes. Willing and available for a three years study.
Exclusion Criteria:
- Pregnant women. Subjects with major illness such as cancer, hepatic or cardiac diseases. Tranferable jobs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Reduction in conversion of IGT to diabetes
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Secondary Outcome Measures
Outcome Measure |
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Benefits of the drug on anthropometric variables and biochemical parameters
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ambady Ramachandran, MD,PhD,DSc., Director
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDPP1
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