Normobaric Hypoxic Training and Metabolic Syndrome

NCT01468220 | Completed

• 2 other identifiers: Hypoxitrain 1Hypoximet 1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

tissue metabolism; skeletal muscle; adipose tissue; HIF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

normoxic training

PLACEBO COMPARATOR

6 weeks of endurance training under normoxia

Other: Endurance training

hypoxic training

ACTIVE COMPARATOR

6 weeks of endurance training under hypoxia

Other: Endurance training

Interventions

Endurance training OTHER

Endurance training three times per week over six weeks

hypoxic training; normoxic training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Other relevant metabolic or cardiovascular diseases

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charite University Medicine, ECRC

Berlin, 13125, Germany

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research Associate

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: November 9, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: June 1, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

DE (1)