HealthyNCT00966134
Ghrelin, Growth Hormone and Growth Factors at High Altitude
An observational study of Healthy and Growth Hormone, run by Medical University of Vienna.
Trial summary
Regulation of ghrelin, growth hormone and growth factors at high altitude and their change during ascent to high altitude has not been studied in depth yet. The study includes 33 volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after ascent to 5400-5900m. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Growth Hormone
- What is being tested?
- exposure to high altitude
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2002to Sep 2005
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Caucasians from an Alpinist association
Who may be able to join
- Healthy and good physical fitness
Who cannot join
None listed.
About this study
Regulation of ghrelin, growth hormone and growth factors at high altitude and their change during ascent to high altitude has not been studied in depth yet. The study includes 33 volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after ascent to 5400-5900m.
The investigators hypothesized that during ascent growth hormone levels would increase to compensate for the higher energy needs at high altitude.
- Conditions
- Healthy, Growth Hormone
- Being tested
- exposure to high altitude
- Keywords
- mountain medicine, ghrelin, growth hormone, hypoxia, physiology of hormonal adaptation to high altitude
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to high altitudeOther
| Study group | Role | What they receive |
|---|---|---|
| probands | Not described Receives: Other: exposure to high altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin, growth hormone, insulin-like growth factor I (IGF-I), IGF binding protein 1 (IGFBP1), IGF binding protein 2 (IGFBP2), IGF binding protein 3 (IGFBP3), acid-labile subunit (ALS), insulin, prolactin
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startApr 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966134
- Sponsor's protocol ID
- EK 411
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 23 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin, Growth Hormone and Growth Factors at High Altitude
- ClinicalTrials.gov ID
- NCT00966134
- Acronym / sponsor ID
- EK 411
- Conditions
- Healthy, Growth Hormone
- Keywords
- mountain medicine, ghrelin, growth hormone, hypoxia, physiology of hormonal adaptation to high altitude
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Sep 2005 (actual)
- First posted
- 26 Aug 2009 (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.
Regulation of ghrelin, growth hormone and growth factors at high altitude and their change during ascent to high altitude has not been studied in depth yet. The study includes 33 volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after ascent to 5400-5900m.
The investigators hypothesized that during ascent growth hormone levels would increase to compensate for the higher energy needs at high altitude.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| probands | – | Other: exposure to high altitude |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Caucasians from an Alpinist association
Key inclusion criteria (1 listed)
- Healthy and good physical fitness
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| exposure to high altitude | Other | probands |
Primary outcome
Ghrelin, growth hormone, insulin-like growth factor I (IGF-I), IGF binding protein 1 (IGFBP1), IGF binding protein 2 (IGFBP2), IGF binding protein 3 (IGFBP3), acid-labile subunit (ALS), insulin, prolactin
Time frame: 14 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 23 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Growth Hormone, run by Medical University of Vienna.
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 1 inclusion and 0 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 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Ghrelin, growth hormone, insulin-like growth factor I (IGF-I), IGF binding protein 1 (IGFBP1), IGF binding protein 2 (IGFBP2), IGF binding protein 3 (IGFBP3), acid-labile subunit (ALS), insulin, prolactin (time frame: 14 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 23 Feb 2010.