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临床试验/NCT00279240
NCT00279240已完成1 期

The Indian Diabetes Prevention Programme Shows That Lifestyle Modification and Metformin Prevent Type 2 Diabetes in Asian Indian Subjects With Impaired Glucose Tolerance (IDPP1)

M.V. Hospital for Diabetes1 个研究点 分布在 1 个国家开始时间: 2001年3月1日最近更新:
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试验速览

阶段
1 期
状态
已完成
发起方
试验地点
1
主要终点
Reduction in conversion of IGT to diabetes

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Prevention
盲法
None

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Both male and female. 35 - 55 years. No Known history of diabetes. Willing and available for a three years study.

排除标准

  • •Pregnant women. Subjects with major illness such as cancer, hepatic or cardiac diseases. Tranferable jobs.

结局指标

主要结局

Reduction in conversion of IGT to diabetes

次要结局

  • Benefits of the drug on anthropometric variables and biochemical parameters

研究者

发起方
M.V. Hospital for Diabetes
申办方类型
Other

研究点 (1)

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