Normobaric Hypoxic Training and Metabolic Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Endurance training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normoxic training<br>6 weeks of endurance training under normoxia | Other: Endurance training<br>* Endurance training three times per week over six weeks<br>|
| Active Comparator: hypoxic training<br>6 weeks of endurance training under hypoxia | Other: Endurance training<br>* Endurance training three times per week over six weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue metabolism, skeletal muscle, adipose tissue, HIF