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
  Purpose

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.


Condition Intervention
Hypobaric Hypoxia
Metabolomics
Oxidative Stress
Acute Mountain Sickness
Other: Hypoxic exposure

Study Type: Interventional
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

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Number of volunteers with acute mountain sickness [ Time Frame: during ascent, expected to be approximately 19-23 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: March 2005
Study Completion Date: February 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Hypoxic exposure
    Hypoxic exposure
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436383

Locations
Switzerland
Center of Laboratory Medicine
Aarau, Switzerland, 5001
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Kantonsspital Aarau
Investigators
Study Chair: Andreas Huber, Prof. Dr. med. Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau
  More Information

No publications provided

Responsible Party: Prof. Dr. med. A. R. Huber, Center of Laboratory Medicine, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT01436383     History of Changes
Other Study ID Numbers: KEK 1189, SNSF 3200B0-108300
Study First Received: September 14, 2011
Last Updated: September 20, 2011
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Keywords provided by University Hospital Inselspital, Berne:
high altitude
hypobaric hypoxia
metabolomics
oxidative stress
acute mountain sickness

Additional relevant MeSH terms:
Altitude Sickness
Anoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014