Hypobaric HypoxiaNCT01436383
Oxidative Stress in Hypobaric Hypoxia
A study testing Hypoxic exposure in people with Hypobaric Hypoxia and Metabolomics, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypobaric Hypoxia, Metabolomics, Oxidative Stress
- What is being tested?
- Hypoxic exposure
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2005to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- physical fit
- mountaineering experience
- 18-70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators
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.
Read the 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
- Being tested
- Hypoxic exposure
- Keywords
- high altitude, hypobaric hypoxia, metabolomics, oxidative stress, acute mountain sickness
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic exposureOther
Hypoxic exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of volunteers with acute mountain sickness
Measured: during ascent, expected to be approximately 19-23 days
Secondary outcomes (3)
Change from baseline in oxygen saturation in blood
Measured: during ascent, expected to be approximately 19-23 days
Changes from baseline in oxidative stress
Measured: during ascent, expected to be approximately 19-23 days
Changes from baseline in different metabolic pathways
Measured: during ascent, expected to be approximately 19-23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypobaric HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Kantonsspital Aarau
- Investigators
- Andreas Huber, Prof. Dr. med., Study chair, Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436383
- Sponsor's protocol ID
- KEK 1189
- Other IDs
- SNSF 3200B0-108300
- Status last verified
- Sep 2011
- First submitted
- 14 Sep 2011
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators
- ClinicalTrials.gov ID
- NCT01436383
- Acronym / sponsor ID
- KEK 1189
- Keywords
- high altitude, hypobaric hypoxia, metabolomics, oxidative stress, acute mountain sickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Kantonsspital Aarau
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy
- physical fit
- mountaineering experience
- 18-70 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxic exposureHypoxic exposure | Other | – |
Primary outcome
Number of volunteers with acute mountain sickness
Time frame: during ascent, expected to be approximately 19-23 days
3 secondary outcomes
Change from baseline in oxygen saturation in blood
Time frame: during ascent, expected to be approximately 19-23 days
Changes from baseline in oxidative stress
Time frame: during ascent, expected to be approximately 19-23 days
Changes from baseline in different metabolic pathways
Time frame: during ascent, expected to be approximately 19-23 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
Related trials for Hypobaric Hypoxia
Enrolling by invitationEarly Phase 1
Program Protocol for a Population That Works in Conditions of Hypobaric Hypoxia
Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions, Changes in Blood Glucose Under Hypobaric Hypoxia Conditions
Active, not recruitingPhase 4
Pharmacological Countermeasures for High Altitude
Hypobaric Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Huber, Prof. Dr. med. study chair
Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic exposure in people with Hypobaric Hypoxia and Metabolomics, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of volunteers with acute mountain sickness (time frame: during ascent, expected to be approximately 19-23 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.