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Sponsored by: |
M.V. Hospital for Diabetes |
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Information provided by: | M.V. Hospital for Diabetes |
ClinicalTrials.gov Identifier: | NCT00279240 |
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 I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label |
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 |
Estimated Study Completion Date: | December 2004 |
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.
Ages Eligible for Study: | 35 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India, Tamilnadu | |
Diabetes Research Centre & MV Hospital for Diabetes | |
Chennai, Tamilnadu, India, 600013 |
Principal Investigator: | Ambady Ramachandran, MD,PhD,DSc. | Director |
Study ID Numbers: | IDPP1 |
Study First Received: | January 18, 2006 |
Last Updated: | January 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00279240 History of Changes |
Health Authority: | India: Institutional Review Board |
Impaired glucose tolerance Intervention Prevention |
Hypoglycemic Agents Hyperglycemia Metabolic Diseases Metformin Glucose Intolerance Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Hyperglycemia Metabolic Diseases Physiological Effects of Drugs Metformin Glucose Intolerance |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |