Normobaric Hypoxic Training and Metabolic Syndrome

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01468220

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: Endurance training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: normoxic training 6 weeks of endurance training under normoxia	Other: Endurance training Endurance training three times per week over six weeks
Active Comparator: hypoxic training 6 weeks of endurance training under hypoxia	Other: Endurance training Endurance training three times per week over six weeks

Arm

Intervention/Treatment

Placebo Comparator: normoxic training

6 weeks of endurance training under normoxia

Other: Endurance training

Endurance training three times per week over six weeks

Active Comparator: hypoxic training

6 weeks of endurance training under hypoxia

Other: Endurance training

Endurance training three times per week over six weeks

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite University Medicine, ECRC	Berlin		Germany	13125

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Boschmann, MD, Research Associate, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01468220

Other Study ID Numbers:

Hypoxitrain 1
Hypoximet 1

First Posted:

Nov 9, 2011

Last Update Posted:

Mar 4, 2019

Last Verified:

Mar 1, 2019

Keywords provided by Michael Boschmann, MD, Research Associate, Charite University, Berlin, Germany

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Mar 4, 2019