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临床试验/NCT01468220
NCT01468220已完成不适用

Normobaric Hypoxic Training Compared to Ambient Training on the Course of the Metabolic Syndrome

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2012年1月最近更新:
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
27
试验地点
2
主要终点
Increase in mitochondria number in skeletal muscle with exercise in hypoxia compared to normoxia

研究概览

简要总结

The patient numbers with metabolic syndrome and diabetes have doubled in the last decade. Data that physical exercise ameliorates the metabolic syndrome are convincing, although the mechanisms of the effect in man are not clear. Numerous endocrine or molecular mechanisms modified by physical exercise are known to be hypoxia-sensitive, i.e. by hypoxia-inducible factor-1 (HIF-1) regulation. Thus, relative hypoxia may link physical exercise and modification of endogenous metabolism. Medical communities seem ill equipped to address the primary issues involved. The investigators have experience with normobaric "hypoxia chambers" and will now test a (physical exercise) training program, using state-of-the-art assessments available nowhere else in Germany. The investigators will compare hypoxia chamber, to ambient training, to test the notion that specific exercise conditions could regulate specific molecular pathways involved in the pathogenesis of the metabolic syndrome. Indeed, hypoxia chamber training could be superior to conventional training in terms of reducing cardiovascular risk factors or improving fitness. The investigators will test overall metabolism-related effects with a metabolic chamber. The investigators will test local metabolism with microdialysis during exercise routines, and the investigators will perform fat and muscle biopsies to investigate tissue-related effects. The investigators include experience from a broad-ranging spectrum. The investigators findings might improve understanding mechanisms linking physical exercise and endogenous metabolism. Furthermore, they could influence decision-making regarding non-pharmacological interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

  • Body mass index 27-40 kg/m2
  • Abdominal obesity (waist circumference >102 cm form men, >88 cm for women)
  • Two further diagnostic criteria of metabolic syndrome (ATP III Definition):
  • HDL cholesterin <40 mg/dl for men, <50 mg/dl for men
  • Triglyceride >150 mg/dl
  • Fasting glucose >110 mg/dl
  • Blood pressure >135/80 mm Hg
  • Less than 2 hours of physical activity per week
  • Sinus rhythm

排除标准

  • Other relevant metabolic or cardiovascular diseases

研究组 & 干预措施

normoxic training

Placebo Comparator

6 weeks of endurance training under normoxia

干预措施: Endurance training (Other)

hypoxic training

Active Comparator

6 weeks of endurance training under hypoxia

干预措施: Endurance training (Other)

结局指标

主要结局

Increase in mitochondria number in skeletal muscle with exercise in hypoxia compared to normoxia

时间窗: Participants will be followed for the duration of the training program, an expected average of 6 weeks

次要结局

未报告次要终点

研究者

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

Michael Boschmann

MD, Research Associate

Charite University, Berlin, Germany

研究点 (2)

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