Normobaric Hypoxic Training and Metabolic Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Endurance training

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Charite University Medicine, ECRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: skeletal muscle; adipose tissue; HIF; tissue metabolism
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: Hypoxitrain 1; Hypoximet 1 (Other Grant/Funding Number: DFG_LU_435_12/1)