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临床试验/NCT04516018
NCT04516018已完成不适用

The Effect of Prolonged Shivering Thermogenesis on Glucose Homeostasis in Overweight/Obese Humans

Maastricht University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
area under the curve (AUC) of the glucose tolerance test

研究概览

简要总结

The purpose of this study is to investigate the effect of prolonged shivering thermogenesis on glucose homeostasis in overweight/obese humans.

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

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Caucasian
  • Healthy (as determined by dependent physician based on medical questionnaire)
  • Man, or postmenopausal (defined as at least 1year post cessation of menses) woman
  • Aged 40 - 75 years at the start of the study
  • BMI 27 and 35 kg/m2
  • Stable dietary habits (no weight loss or gain >3kg in the past 3 months)

排除标准

  • - Not meeting all inclusion criteria
  • Medication use known to hamper subject's safety during study procedures
  • Co-morbidities to which the intervention or program that may pose as a complicating factor
  • Subjects diagnosed with cardiovascular diseases or cancer
  • Fasting plasma glucose ≥ 7.0 mmol/l
  • Haemoglobin < 7.8 mmol/l for women, or < 8.4 mmol/l for men
  • Previously diagnosed with type 2 diabetes
  • Abuse alcohol/drug abuse
  • Subjects who do not want to be informed about unexpected medical findings during the screening/study or do not wish that their physician is informed.
  • Engagement in structured exercise > 2h per week
  • Participation in another biomedical study within 1 month before the first study
  • Cold-acclimated, such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study

结局指标

主要结局

area under the curve (AUC) of the glucose tolerance test

时间窗: 1 day following cold exposure and following 9 consecutive days of cold exposure

area under the curve (AUC) of the glucose tolerance test before cold exposure, 1 day after cold exposure and after 9 consecutive days of cold exposure.

次要结局

  • skeletal muscle GLUT4 translocation(1 day following cold exposure and following 9 consecutive days of cold exposure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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