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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01436383
Other study ID # KEK 1189
Secondary ID SNSF 3200B0-1083
Status Completed
Phase N/A
First received September 14, 2011
Last updated September 20, 2011
Start date March 2005
Est. completion date February 2010

Study information

Verified date September 2011
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Independent Local Research Ethic Commission (Ethikkommission)
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 2010
Est. primary completion date December 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
Hypoxic exposure
Hypoxic exposure

Locations

Country Name City State
Switzerland Center of Laboratory Medicine Aarau

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne Kantonsspital Aarau, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of volunteers with acute mountain sickness during ascent, expected to be approximately 19-23 days No
Secondary Change from baseline in oxygen saturation in blood during ascent, expected to be approximately 19-23 days No
Secondary Changes from baseline in oxidative stress during ascent, expected to be approximately 19-23 days Yes
Secondary Changes from baseline in different metabolic pathways during ascent, expected to be approximately 19-23 days No
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