Clinical trial NCT01436383: Oxidative Stress in Hypobaric Hypoxia
Official title: Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypobaric Hypoxia
Metabolomics
Oxidative Stress
Acute Mountain Sickness
Keywords: high altitude
hypobaric hypoxia
metabolomics
oxidative stress
acute mountain sickness
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Kantonsspital Aarau
First posted: 2011-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Number of volunteers with acute mountain sickness
timeFrame: during ascent, expected to be approximately 19-23 days
Secondary outcomes:
measure: Change from baseline in oxygen saturation in blood
timeFrame: during ascent, expected to be approximately 19-23 days
measure: Changes from baseline in oxidative stress
timeFrame: during ascent, expected to be approximately 19-23 days
measure: Changes from baseline in different metabolic pathways
timeFrame: during ascent, expected to be approximately 19-23 days
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Center of Laboratory Medicine
Study officials:
affiliation: Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau
name: Andreas Huber, Prof. Dr. med.
role: STUDY_CHAIR
References: