Oxidative Stress in Hypobaric Hypoxia

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01436383
Study type	Interventional
Source	University Hospital Inselspital, Berne
Contact
Status	Completed
Phase	N/A
Start date	March 2005
Completion date	February 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.