Oxidative Stress in Hypobaric Hypoxia

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Brief Title

Oxidative Stress in Hypobaric Hypoxia

Official Title

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

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
    


Study Type

Interventional


Primary Outcome

Number of volunteers with acute mountain sickness

Secondary Outcome

 Change from baseline in oxygen saturation in blood

Condition

Hypobaric Hypoxia

Intervention

Hypoxic exposure


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

36

Start Date

March 2005

Completion Date

February 2010

Primary Completion Date

December 2005

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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Andreas Huber, Prof. Dr. med., , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT01436383

Organization ID

KEK 1189

Secondary IDs

SNSF 3200B0-108300


Study Sponsor

University Hospital Inselspital, Berne

Collaborators

 Swiss National Science Foundation

Study Sponsor

Andreas Huber, Prof. Dr. med., Study Chair, Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau


Verification Date

September 2011