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临床试验/NCT01872533
NCT01872533已完成1 期

Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
9
试验地点
1
主要终点
Change in Insulin sensitivity

研究概览

简要总结

The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to moderate hypoxia (~ 15% O2, similar to conditions at an altitude of ~7500 feet) will improve glucose metabolism.

研究设计

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

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Aged 20-45 years
  • •Obese category (BMI > 30 kg/m2)
  • •Healthy as assessed by a self-reported health questionnaire
  • •Non-smokers
  • •Weight stable over the past 3 months (<2kg fluctuation)

排除标准

  • •Sleep apnea
  • •Hypertension
  • •History of altitude sickness
  • •Individuals taking any chronic medications
  • •Individuals taking any stimulants
  • •Individuals taking beta-blockers
  • •Individuals with chronic alcohol consumption (>3 drinks per day) or drug abuse.
  • •Individuals unable to abstain from caffeinated beverage or alcohol the days of study testing
  • •Individuals with history disease or history of stroke

研究组 & 干预措施

Hypoxia Exposure

Experimental

There was only one study arm: All participants slept in moderate hypoxia (see description below).

干预措施: Hypoxia Exposure (Other)

结局指标

主要结局

Change in Insulin sensitivity

时间窗: Change from baseline to 10 nights of hypoxia exposure

Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.

次要结局

  • Change in oxygen tension in adipose tissue(Before and after 10 nights of hypoxia exposure)
  • Change in gene and protein expression(Before and after 10 nights of hypoxia exposure)
  • Glucose uptake in myotubes(Before 10 nights of hypoxia exposure)

研究者

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

Eric Ravussin

Principal Investigator

Pennington Biomedical Research Center

研究点 (1)

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