Oxidative Stress in Hypobaric Hypoxia

This study has been completed.
Sponsor:
Collaborators:
Swiss National Science Foundation
Kantonsspital Aarau
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01436383
First received: September 14, 2011
Last updated: September 20, 2011
Last verified: September 2011

September 14, 2011
September 20, 2011
March 2005
December 2005   (final data collection date for primary outcome measure)
Number of volunteers with acute mountain sickness [ Time Frame: during ascent, expected to be approximately 19-23 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01436383 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Oxidative Stress in Hypobaric Hypoxia
Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators

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.

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hypobaric Hypoxia
  • Metabolomics
  • Oxidative Stress
  • Acute Mountain Sickness
Other: Hypoxic exposure
Hypoxic exposure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2010
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01436383
KEK 1189, SNSF 3200B0-108300
Yes
Prof. Dr. med. A. R. Huber, Center of Laboratory Medicine, Kantonsspital Aarau
University Hospital Inselspital, Berne
  • Swiss National Science Foundation
  • Kantonsspital Aarau
Study Chair: Andreas Huber, Prof. Dr. med. Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau
University Hospital Inselspital, Berne
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP