Oxidative Stress in Hypobaric Hypoxia
Primary Purpose
Hypobaric Hypoxia, Metabolomics, Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hypoxic exposure
Sponsored by
About this trial
This is an interventional basic science trial for Hypobaric Hypoxia focused on measuring high altitude, hypobaric hypoxia, metabolomics, oxidative stress, acute mountain sickness
Eligibility Criteria
Inclusion Criteria:
- healthy
- physical fit
- mountaineering experience
- 18-70 years
Exclusion Criteria
- any type of disease
- regular intake of medicaments
- history of high altitude pulmonary edema
- severe acute mountain sickness below an altitude of 3500m
- any history of high altitude cerebral edema
Sites / Locations
- Center of Laboratory Medicine
Outcomes
Primary Outcome Measures
Number of volunteers with acute mountain sickness
Secondary Outcome Measures
Change from baseline in oxygen saturation in blood
Changes from baseline in oxidative stress
Changes from baseline in different metabolic pathways
Full Information
NCT ID
NCT01436383
First Posted
September 14, 2011
Last Updated
September 20, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation, Kantonsspital Aarau
1. Study Identification
Unique Protocol Identification Number
NCT01436383
Brief Title
Oxidative Stress in Hypobaric Hypoxia
Official Title
Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation, Kantonsspital Aarau
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The trial investigates changes in metabolism during high altitude expedition up to 6865m. A mass-spectrometry based platform is used to detect different oxidative stress related metabolites. Symptoms of acute mountain sickness are evaluated and correlated with laboratory parameters.
Detailed Description
Background
Altitude related illness, which include acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE), is common in subjects exposed to high altitude during professional or leisure time activities. There are independent risk factors such as: individual susceptibility and rate of ascent. HAPE is a potentially life-threatening complication of high altitude stay, mostly occuring within the first 2-5 days of exposure. Although there is a controversial discussion, excessive hypoxic pulmonary vasoconstriction is thought to be the main trigger for developing HAPE. Beside the controversial discussion if hypobaric hypoxia leads to oxidative stress it is not known whether oxidative stress contributes to AMS or HAPE.
Objective
The investigators hypothesize that reactive oxygen species are generated during high altitude stay and contribute to the development of acute mountain sickness. Furthermore they would like to describe other changes in metabolic pathways possibly contributing to vessel tone dysregulation.
Methods
36 healthy volunteers will examined during an high altitude medical research expedition to Mount Muztagh ata (7549m) in Western China. Acute mountain sickness scores and clinical parameters will be assessed. Metabolomics analysis of more than 390 parameters, using a mass spectrometry-based targeted metabolomic platform, is used to detect systemic oxidative stress and functional impairment of enzymes that require oxidation-sensitive co-factors. Furthermore routine laboratory test will be done, for example CRP, creatinine and interleukines
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypobaric Hypoxia, Metabolomics, Oxidative Stress, Acute Mountain Sickness
Keywords
high altitude, hypobaric hypoxia, metabolomics, oxidative stress, acute mountain sickness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Hypoxic exposure
Intervention Description
Hypoxic exposure
Primary Outcome Measure Information:
Title
Number of volunteers with acute mountain sickness
Time Frame
during ascent, expected to be approximately 19-23 days
Secondary Outcome Measure Information:
Title
Change from baseline in oxygen saturation in blood
Time Frame
during ascent, expected to be approximately 19-23 days
Title
Changes from baseline in oxidative stress
Time Frame
during ascent, expected to be approximately 19-23 days
Title
Changes from baseline in different metabolic pathways
Time Frame
during ascent, expected to be approximately 19-23 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
physical fit
mountaineering experience
18-70 years
Exclusion Criteria
any type of disease
regular intake of medicaments
history of high altitude pulmonary edema
severe acute mountain sickness below an altitude of 3500m
any history of high altitude cerebral edema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Huber, Prof. Dr. med.
Organizational Affiliation
Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau
Official's Role
Study Chair
Facility Information:
Facility Name
Center of Laboratory Medicine
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
12. IPD Sharing Statement
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Oxidative Stress in Hypobaric Hypoxia
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