Life Style Modifications Prevents Type 2 Diabetes in Asian Indians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279240
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : January 24, 2006
Information provided by:
M.V. Hospital for Diabetes

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Drug: Metformin Phase 1

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 : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (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)
Study Start Date : March 2001
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Reduction in conversion of IGT to diabetes

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279240

Diabetes Research Centre & MV Hospital for Diabetes
Chennai, Tamilnadu, India, 600013
Sponsors and Collaborators
M.V. Hospital for Diabetes
Principal Investigator: Ambady Ramachandran, MD,PhD,DSc. Director Identifier: NCT00279240     History of Changes
Other Study ID Numbers: IDPP1
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: January 24, 2006
Last Verified: July 2002

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs