Normobaric Hypoxic Training and Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Endurance training

• Registration Number: NCT01468220
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-09
• Study Start: 2012-01
• Primary Completion: 2017-07
• Study Completion: 2018-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normoxic training	Endurance training	6 weeks of endurance training under normoxia
hypoxic training	Endurance training	6 weeks of endurance training under hypoxia

Primary Outcome Measures

Name	Time	Method
Increase in mitochondria number in skeletal muscle with exercise in hypoxia compared to normoxia	Participants will be followed for the duration of the training program, an expected average of 6 weeks

Trial Locations

Locations (1)

Charite University Medicine, ECRC; 🇩🇪 Berlin, Germany