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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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00279240
Enrollment
Unknown
Registered
2006-01-19
Start date
2001-03-31
Completion date
2004-12-31
Last updated
2006-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Impaired glucose tolerance, Intervention, Prevention

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

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.

Interventions

DRUGMetformin

Sponsors

M.V. Hospital for Diabetes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frame
Reduction in conversion of IGT to diabetes

Secondary

MeasureTime frame
Benefits of the drug on anthropometric variables and biochemical parameters

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026