Clinical trial NCT01468220: Normobaric Hypoxic Training and Metabolic Syndrome
Official title: Normobaric Hypoxic Training Compared to Ambient Training on the Course of the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: tissue metabolism
skeletal muscle
adipose tissue
HIF
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Increase in mitochondria number in skeletal muscle with exercise in hypoxia compared to normoxia
timeFrame: Participants will be followed for the duration of the training program, an expected average of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine, ECRC
Study officials:
References: