Life Style Modifications Prevents Type 2 Diabetes in Asian Indians

This study has been completed.
Sponsor:
Information provided by:
M.V. Hospital for Diabetes
ClinicalTrials.gov Identifier:
NCT00279240
First received: January 18, 2006
Last updated: January 23, 2006
Last verified: July 2002
  Purpose

Three year prospective randomised controlled trial in IGT subjects to study the effect of metformin and lifestyle modification in preventing the conversion to diabetes


Condition Intervention Phase
Diabetes
Drug: Metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Indian Diabetes Prevention Programme Shows That Lifestyle Modification and Metformin Prevent Type 2 Diabetes in Asian Indian Subjects With Impaired Glucose Tolerance (IDPP1)

Resource links provided by NLM:


Further study details as provided by M.V. Hospital for Diabetes:

Primary Outcome Measures:
  • Reduction in conversion of IGT to diabetes

Secondary Outcome Measures:
  • Benefits of the drug on anthropometric variables and biochemical parameters

Study Start Date: March 2001
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00279240

Locations
India
Diabetes Research Centre & MV Hospital for Diabetes
Chennai, Tamilnadu, India, 600013
Sponsors and Collaborators
M.V. Hospital for Diabetes
Investigators
Principal Investigator: Ambady Ramachandran, MD,PhD,DSc. Director
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279240     History of Changes
Other Study ID Numbers: IDPP1
Study First Received: January 18, 2006
Last Updated: January 23, 2006
Health Authority: India: Institutional Review Board

Keywords provided by M.V. Hospital for Diabetes:
Impaired glucose tolerance
Intervention
Prevention

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014