Life Style Modifications Prevents Type 2 Diabetes in Asian Indians

Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279240
• Other study ID #: IDPP1
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2006
• Last updated: January 23, 2006
• Start date: March 2001
• Est. completion date: December 2004

Study information

• Verified date: July 2002
• Source: M.V. Hospital for Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
India	Diabetes Research Centre & MV Hospital for Diabetes	Chennai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
M.V. Hospital for Diabetes

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in conversion of IGT to diabetes
Secondary	Benefits of the drug on anthropometric variables and biochemical parameters