Oxidative Stress in Hypobaric Hypoxia

Not Applicable

Completed

• Conditions: Acute Mountain Sickness; Oxidative Stress; Metabolomics; Hypobaric Hypoxia

• Registration Number: NCT01436383
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-12
• Study Completion: 2010-02
• Status Verified: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of volunteers with acute mountain sickness	during ascent, expected to be approximately 19-23 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in oxygen saturation in blood	during ascent, expected to be approximately 19-23 days
Changes from baseline in different metabolic pathways	during ascent, expected to be approximately 19-23 days
Changes from baseline in oxidative stress	during ascent, expected to be approximately 19-23 days

Trial Locations

Locations (1)

Center of Laboratory Medicine; 🇨🇭 Aarau, Switzerland