NCT01436383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

September 14, 2011

Last Update Submit

September 20, 2011

Conditions

Hypobaric HypoxiaMetabolomicsOxidative StressAcute Mountain Sickness

Keywords

high altitudehypobaric hypoxiametabolomicsoxidative stressacute mountain sickness

Outcome Measures

Primary Outcomes (1)

  • Number of volunteers with acute mountain sickness

    during ascent, expected to be approximately 19-23 days

Secondary Outcomes (3)

  • Change from baseline in oxygen saturation in blood

    during ascent, expected to be approximately 19-23 days

  • Changes from baseline in oxidative stress

    during ascent, expected to be approximately 19-23 days

  • Changes from baseline in different metabolic pathways

    during ascent, expected to be approximately 19-23 days

Interventions

Hypoxic exposureOTHER

Hypoxic exposure

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy
  • physical fit
  • mountaineering experience
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Laboratory Medicine

Aarau, 5001, Switzerland

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Andreas Huber, Prof. Dr. med.

    Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 19, 2011

Study Start

March 1, 2005

Primary Completion

December 1, 2005

Study Completion

February 1, 2010

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations

CH(1)