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

January 18, 2006
January 23, 2006
March 2001
Not Provided
Reduction in conversion of IGT to diabetes
Same as current
Complete list of historical versions of study NCT00279240 on ClinicalTrials.gov Archive Site
Benefits of the drug on anthropometric variables and biochemical parameters
Same as current
Not Provided
Not Provided
 
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)

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

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.

Interventional
Phase 1
Allocation: Randomized
Masking: Open Label
Primary Purpose: Prevention
Diabetes
Drug: Metformin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2004
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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.
Both
35 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00279240
IDPP1
Not Provided
Not Provided
M.V. Hospital for Diabetes
Not Provided
Principal Investigator: Ambady Ramachandran, MD,PhD,DSc. Director
M.V. Hospital for Diabetes
July 2002

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