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临床试验/NCT02065544
NCT02065544已完成不适用

Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise

University of Vermont0 个研究点目标入组 12 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
主要终点
Hemoglobin A1c

研究概览

简要总结

This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.

详细描述

This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.

The study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. > 50%) for individuals in the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • new diagnosis of type 2 diabetes since 12 months
  • HBA1c > 6.5, , 8.0

排除标准

  • HBA1c >8.0

结局指标

主要结局

Hemoglobin A1c

时间窗: 6-months

HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.

次要结局

  • lipid profile(6 months)
  • HS-C Reactive Protein(6 months)
  • Aerobic Fitness(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Ades

Professor of Medicine

University of Vermont

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