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临床试验/NCT02196623
NCT02196623已完成不适用

Hypoxia and Aerobic Exercise Interactions in Age-related Metabolic Muscle Dysfunction

Hannover Medical School2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Insulin sensitivity

研究概览

简要总结

Ageing is the primary risk factor for most chronic diseases including type 2 diabetes mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic disease and frailty, which limits physical mobility as well as quality of life, share common cellular mechanisms.

The investigators will test the hypothesis that a combination of normobaric hypoxia and exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle dysfunction and the investigators will address the molecular mechanisms. In a randomized clinical study, the investigators will compare normoxic and hypoxic training conditions in elderly subjects. Outcome measures will focus on whole body insulin sensitivity and mitochondrial responses in skeletal muscle before and after the 8-week training intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 55 to 75 years of age
  • body mass index: 20 - 35 kg/m2
  • weight stable during last 6 months before screening (weight change < 2% body weight)
  • HOMA-index of insulin resistance ≥ 2 to 4 units

排除标准

  • more than 1 hour of scheduled exercise training per week
  • known diagnosis of type 2 diabetes or measured HbA1c > 6,5%
  • known drug or alcohol abuse
  • any contraindication to perform exercise training
  • acute or chronic infections
  • increased bleeding risk by history, INR > 1,3, use of anticoagulants

研究组 & 干预措施

Hypoxic Exercise

Experimental

Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions

干预措施: Hypoxic exercise (Other)

Normoxic exercise

Sham Comparator

Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions

干预措施: Normoxic Exercise (Other)

结局指标

主要结局

Insulin sensitivity

时间窗: At baseline and after 8 weeks

Insulin sensitivity is assessed via the hyperinsulinemic euglycemic glucose clamp and expressed as the glucose infusion rate (GIR) in ml

次要结局

  • Maximum oxygen uptake(At baseline and after 8 weeks)
  • Mitochondrial number(At baseline and after 8 weeks)
  • Body fat and body fat free mass(At baseline and after 8 weeks)
  • Fat and carbohydrate oxidation during exercise(At baseline and after 8 weeks)
  • Health related quality of life(At baseline and after 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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