Normobaric Hypoxic Training and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468220
• Other study ID #: Hypoxitrain 1
• Secondary ID: Hypoximet 1
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: June 2018

Study information

• Verified date: March 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Endurance training
Endurance training three times per week over six weeks

Locations

Country	Name	City	State
Germany	Charite University Medicine, ECRC	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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