Normobaric Hypoxic Training and Metabolic Syndrome

NCT ID: NCT01468220

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

normoxic training

6 weeks of endurance training under normoxia

Group Type: PLACEBO_COMPARATOR

Endurance training

Intervention Type: OTHER

Endurance training three times per week over six weeks

hypoxic training

6 weeks of endurance training under hypoxia

Group Type: ACTIVE_COMPARATOR

Endurance training

Intervention Type: OTHER

Endurance training three times per week over six weeks

Interventions

Endurance training

Endurance training three times per week over six weeks

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Michael Boschmann

MD, Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charite University Medicine, ECRC

Berlin, , Germany

Countries

Germany

Other Identifiers

Hypoximet 1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Hypoxitrain 1

Identifier Type: -

Identifier Source: org_study_id