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Oxidative Stress in Hypobaric Hypoxia

Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01436383
Enrollment
36
Registered
2011-09-19
Start date
2005-03-31
Completion date
2010-02-28
Last updated
2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Mountain Sickness, Hypobaric Hypoxia, Metabolomics, Oxidative Stress

Keywords

high altitude, hypobaric hypoxia, metabolomics, oxidative stress, acute mountain sickness

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

Interventions

Hypoxic exposure

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
Kantonsspital Aarau
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Number of volunteers with acute mountain sicknessduring ascent, expected to be approximately 19-23 days

Secondary

MeasureTime frame
Change from baseline in oxygen saturation in bloodduring ascent, expected to be approximately 19-23 days
Changes from baseline in oxidative stressduring ascent, expected to be approximately 19-23 days
Changes from baseline in different metabolic pathwaysduring ascent, expected to be approximately 19-23 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026