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临床试验/CTRI/2016/11/007488
CTRI/2016/11/007488已完成3 期

effectiveness of structured exercise program on insulin resistance and quality of life in type 2 diabetes mellitus

Manipal University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年1月7日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
240
试验地点
1
主要终点
fasting insulin level, HOMA-IR, six minute walk test, quality of life by WHOQOL-BREF.

研究概览

简要总结

Background: People living with the type 2 diabetes is increasing alarmingly in India. In literature much attention given towards diabetic foot and its management and less focus is devoted to Diabetes affecting on physical activity and strength.

Literature gap:

Very few RCT`s with smaller sample size were available in the literature globally. Even though prevalence of T2DM increasing rapidly in Indian population there is a dearth of literature on exercise training on insulin resistance in T2DM.

Need for the Project:

Even though the prevalence of diabetes mellitus is increasing in India, focus is on management of hyperglycemia and subsequent complications.  Based on the literature we observed even though till date T2DM is highly prevalent & develops IR, there are only few studies available with the effectiveness of exercise on IR which  leads to an exercise intolerance in T2DM, which reduces function & altered quality of life which one again had influence on glycemic control.Therefore there is a need to study the exercise intolerance in T2DM

 There is dearth of literature on combined aerobic and resistance training on insulin resistance in type 2 diabetes mellitus in Indian population.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • participants with type diabetes mellitus on oral hypoglycemic agent with or without insulin theray.

排除标准

  • participants with type 1 diabetes mellitus, pregnancy, thyroid disorder.

结局指标

主要结局

fasting insulin level, HOMA-IR, six minute walk test, quality of life by WHOQOL-BREF.

时间窗: baseline and at 3rd month

次要结局

  • fasting blood sugar,body composition analysis, HbA1c, Physical activity using GPAQ questionnaire.(baseline and at 3rd month)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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