Oxidative Stress in Hypobaric Hypoxia

Oxidative Stress Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• Hypobaric Hypoxia
• Metabolomics
• Oxidative Stress

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