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Normobaric Hypoxic Training and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endurance training
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring tissue metabolism, skeletal muscle, adipose tissue, HIF

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University Medicine, ECRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

normoxic training

hypoxic training

Arm Description

6 weeks of endurance training under normoxia

6 weeks of endurance training under hypoxia

Outcomes

Primary Outcome Measures

Increase in mitochondria number in skeletal muscle with exercise in hypoxia compared to normoxia

Secondary Outcome Measures

Full Information

First Posted
September 15, 2011
Last Updated
March 1, 2019
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01468220
Brief Title
Normobaric Hypoxic Training and Metabolic Syndrome
Official Title
Normobaric Hypoxic Training Compared to Ambient Training on the Course of the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
tissue metabolism, skeletal muscle, adipose tissue, HIF

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normoxic training
Arm Type
Placebo Comparator
Arm Description
6 weeks of endurance training under normoxia
Arm Title
hypoxic training
Arm Type
Active Comparator
Arm Description
6 weeks of endurance training under hypoxia
Intervention Type
Other
Intervention Name(s)
Endurance training
Intervention Description
Endurance training three times per week over six weeks
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Charite University Medicine, ECRC
City
Berlin
ZIP/Postal Code
13125
Country
Germany

12. IPD Sharing Statement

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Normobaric Hypoxic Training and Metabolic Syndrome

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