Oxidative Stress in Hypobaric Hypoxia
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.
Acute Mountain Sickness
Other: Hypoxic exposure
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators|
- Number of volunteers with acute mountain sickness [ Time Frame: during ascent, expected to be approximately 19-23 days ] [ Designated as safety issue: No ]
- Change from baseline in oxygen saturation in blood [ Time Frame: during ascent, expected to be approximately 19-23 days ] [ Designated as safety issue: No ]
- Changes from baseline in oxidative stress [ Time Frame: during ascent, expected to be approximately 19-23 days ] [ Designated as safety issue: Yes ]
- Changes from baseline in different metabolic pathways [ Time Frame: during ascent, expected to be approximately 19-23 days ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Other: Hypoxic exposure
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.
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436383
|Center of Laboratory Medicine|
|Aarau, Switzerland, 5001|
|Study Chair:||Andreas Huber, Prof. Dr. med.||Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau|