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临床试验/NCT02852759
NCT02852759已完成不适用

A Cold Physical Treatment to Manage Insulin Resistance

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年7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
33
试验地点
1
主要终点
Change of Glucose Tolerance measured by OGTT

研究概览

简要总结

Insulin resistant volunteers will choose to undergo an 8-week cold treatment, 2 hours per day, to selective regions of the body enriched with brown fat including neck, supraclavicular and interscapular regions) in combination with electroacupuncture (EA). Their insulin sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation will be assessed by positron emission tomography and computed tomography (PET/CT)-scans and/or serum marker measurements.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI: 20-30
  • Insulin resistant

排除标准

  • uncontrolled hypertension
  • insulin dependent diabetics
  • heart diseases
  • hyperthyroidism
  • secondary obesity
  • surgical operation within treatment or planned in two months
  • pregnancy
  • liver or kidney failure

结局指标

主要结局

Change of Glucose Tolerance measured by OGTT

时间窗: 0, 8 week, 2 hours for each measurement

glucose tolerance at 8 weeks will be compared to 0 week

次要结局

  • Change of 2-deoxy-2-[fluorine-18]fluoro- D-glucose (FDG) uptake by PET/CT-scans(0 and 8 week, 2 hours for each measurement)
  • Change of serum insulin levels(0, 8 week)
  • Change of Body weight(0, 8 week)
  • Change of glucose infusion rate by hyperinsulinemic euglycemic clamp(0 and 8 week, 5 hours for each measurement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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