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临床试验/NCT02502344
NCT02502344Unknown4 期

The Research About the Influence of Medical Interventions in the Period of Insulin Resistance on Prevalence of Abnormal Glucose Tolerance

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
prevalence of abnormal glucose intolerance

研究概览

简要总结

This research would take medical interventions in subjects of insulin resistance without abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose tolerance in different groups.

详细描述

The situation of type 2 DM prevention in China is serious. The commonly accepted natural course of type 2 DM is as follows: obesity, insulin resistance(hyperinsulemia), abnormal glucose tolerance, DM and complications of DM; correspondently, the function status of pancreas islet β cells are: normal, compensatory, decompensatory, impaired and failure. Post researches have proved that using medical interventions after the period of insulin resistance when the function status of β cells were compensatory, the course could not be reversed. There were few clinical researches about effects of medical interventions in the period of insulin resistance . This research would take medical interventions in subjects of insulin resistance without abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose tolerance in different groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • BMI > 28kg/m2
  • diagnosis of insulin resistance

排除标准

  • abnormal glucose tolerance
  • function impairment of heart, liver or kidney

研究组 & 干预措施

medical intervention group

Experimental

subjects in this group will accept healthy lifestyle changes such as food control and intensive exercise for 3 months first. Then their insulin resistance will be evaluated again . If their insulin resistance didn't improve, then they will take metformin 0.5g qd to reduce insulin resistance. If their insulin resistance improved, they will continued healthy lifestyle changes.

干预措施: healthy lifestyle (Behavioral)

medical intervention group

Experimental

subjects in this group will accept healthy lifestyle changes such as food control and intensive exercise for 3 months first. Then their insulin resistance will be evaluated again . If their insulin resistance didn't improve, then they will take metformin 0.5g qd to reduce insulin resistance. If their insulin resistance improved, they will continued healthy lifestyle changes.

干预措施: Metformin (Drug)

结局指标

主要结局

prevalence of abnormal glucose intolerance

时间窗: two years after the subject joins the research

OGTT test will be took in these subjects to find out if their glucose tolerance was abnormal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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