Normobaric Hypoxic Training and Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Charite University, Berlin, Germany.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Michael Boschmann, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01468220
First received: September 15, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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 Intervention
Metabolic Syndrome
Other: Endurance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Normobaric Hypoxic Training Compared to Ambient Training on the Course of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Increase in mitochondria number in skeletal muscle with exercise in hypoxia compared to normoxia [ Time Frame: Participants will be followed for the duration of the training program, an expected average of 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468220

Contacts
Contact: Michael Boschmann, MD +4930450540241 michael.boschmann@charite.de

Locations
Germany
Charite University Medicine, ECRC Not yet recruiting
Berlin, Germany, 13125
Principal Investigator: Friedrich C Luft, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Michael Boschmann, MD, Research Associate, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01468220     History of Changes
Other Study ID Numbers: Hypoxitrain 1, Hypoximet 1
Study First Received: September 15, 2011
Last Updated: November 7, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
tissue metabolism
skeletal muscle
adipose tissue
HIF

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 31, 2014