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Completed

NCT Number: NCT01468220

Normobaric Hypoxic Training and Metabolic Syndrome

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University Medicine, ECRC

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Other relevant metabolic or cardiovascular diseases

Treatment and study plan

Endurance training

Other

Endurance training three times per week over six weeks

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Nov 9, 2011
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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