Residence or Prolonged Visit at High Altitude as the Cause of Mountain SicknessNCT03446898
A Study of the Effect of High Altitudes on Physiological and Metabolic Markers in Adults Living at Qinghai-Tibet Plateau for Work Purpose
An observational study of Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness, run by Tibetan Traditional Medical College at 1 site in China.
Trial summary
This ambispective cohort study aims to evaluate the effect of high altitudes environment on human's physiological and metabolic markers, specific markers of main human systems, and incidence rate and severity of chronic mountain sickness (CMS). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness
- What is being tested?
- Chronic hypoxic environment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2017to 1 Jul 2019
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is adults who live at Qinghai-Tibet Plateau for Work Purpose.
Who may be able to join
- Be provided verbal or written informed consent;
- Men and women ≥ 30 and ≤ 65 years of age;
- Adults living at Qinghai-Tibet Plateau for Work Purpose, and the altitude of residence is more than 2,500 meters;
- Providing electronical or paper medical examination reports which conducted in 2016.
Who cannot join
- Pregnant or breast-feeding women;
- Be excluded by Principal investigator for subject's compliance or safety reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tibetan Traditional Medical College
Lhasa, Tibet
Yingchun He, Master, +86-13880930756, 17190782@qq.com
Tonghua Liu, Professor, +86-13801020306, thliu@vip.163.com
About this study
Official title: A Cohort Study of the Effect of High Altitudes on Physiological and Metabolic Markers in Adults Who Live at Qinghai-Tibet Plateau for Work Purpose
This ambispective cohort study aims to evaluate the effect of high altitudes environment on human's physiological and metabolic markers, specific markers of main human systems, and incidence rate and severity of chronic mountain sickness (CMS).
Read the detailed description
Qinghai-Tibet plateau is a high altitudes area with average 3,000-5,000 meters height in China. As the partial pressure of oxygen in inspired air falls with increasing terrestrial elevation above sea level, many physiological variables in human body could be affected by this hypobaric hypoxic environment. Up to date, there are no large scale clinical trials assessing these changes in chinese population. The study here would like to provide the newest medical information on the changes of physiological variables and correlation between specific risk factors in chinese adults living at high altitudes for work purpose.
- Being tested
- Chronic hypoxic environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic hypoxic environmentOther
Chronic hypoxic environment. Since the partial pressure of oxygen in inspired air falls with increasing terrestrial elevation above sea level, many physiological variables in adults would be affected by the chronic hypoxia environment.
| Study group | Role | What they receive |
|---|---|---|
| Adults Living at Qinghai-Tibet Plateau for Work Purpose | Qinghai-Tibet Plateau is a high altitude area in which human would be exposed in chronic hypoxia environment. Receives: Other: Chronic hypoxic environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from baseline at first year
Measured: Baseline and 1st year
Change in blood pressure as measured by sphygmomanometer from baseline at first year
The blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.
Measured: Baseline and 1st year
Change in serum lipid from baseline at first year
Measured: Baseline and 1st year
Change in blood glucose from baseline at first year
Measured: Baseline and 1st year
Secondary outcomes (13)
Change in weight from baseline at second year
Measured: Baseline and 2nd year
Change in weight from baseline at third year
Measured: Baseline and 3rd year
Change in blood pressure as measured by sphygmomanometer from baseline at second year
The blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.
Measured: Baseline and 2nd year
Change in blood pressure as measured by sphygmomanometer from baseline at third year
The blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.
Measured: Baseline and 3rd year
Change in serum lipid from baseline at second year
Measured: Baseline and 2nd year
Change in serum lipid from baseline at third year
Measured: Baseline and 3rd year
Change in blood glucose from baseline at second year
Measured: Baseline and 2nd year
Change in blood glucose from baseline at third year
Measured: Baseline and 3rd year
Pathological changes from baseline at first year in human body systems
Measured: Baseline and 1st year
Pathological changes from baseline at second year in human body systems
Measured: Baseline and 2nd year
Pathological changes from baseline at third year in human body systems
Measured: Baseline and 3rd year
The incidence rate and severity of chronic mountain sickness (CMS)
The diagnosis and severity of CMS is identified and assessed using "The Qinghai Chronic Mountain Sickness Score". The score ranges from 0 to 27, and a higher value means a worse outcome.
Measured: The 2nd year
The incidence rate and severity of chronic mountain sickness (CMS)
The diagnosis and severity of CMS is identified and assessed using "The Qinghai Chronic Mountain Sickness Score". The score ranges from 0 to 27, and a higher value means a worse outcome.
Measured: The 3rd year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start22 Jul 2017
- Primary completion22 Mar 2018 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residence or Prolonged Visit at High Altitude as the Cause of Mountain SicknessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tibetan Traditional Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Chengdu University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Tonghua Liu, Professor, Principal investigator, Tibetan Traditional Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446898
- Sponsor's protocol ID
- Z2016B01G03/02-CRP
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of the Effect of High Altitudes on Physiological and Metabolic Markers in Adults Who Live at Qinghai-Tibet Plateau for Work Purpose
- ClinicalTrials.gov ID
- NCT03446898
- Acronym / sponsor ID
- Z2016B01G03/02-CRP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tibetan Traditional Medical CollegeUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Chengdu University of Traditional Chinese Medicine
- Study start
- 22 Jul 2017 (actual)
- Primary completion
- 22 Mar 2018 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 27 Feb 2018 (actual)
- 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.
This ambispective cohort study aims to evaluate the effect of high altitudes environment on human's physiological and metabolic markers, specific markers of main human systems, and incidence rate and severity of chronic mountain sickness (CMS).
Detailed description
Qinghai-Tibet plateau is a high altitudes area with average 3,000-5,000 meters height in China. As the partial pressure of oxygen in inspired air falls with increasing terrestrial elevation above sea level, many physiological variables in human body could be affected by this hypobaric hypoxic environment. Up to date, there are no large scale clinical trials assessing these changes in chinese population. The study here would like to provide the newest medical information on the changes of physiological variables and correlation between specific risk factors in chinese adults living at high altitudes for work purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Living at Qinghai-Tibet Plateau for Work Purpose | – | Other: Chronic hypoxic environmentQinghai-Tibet Plateau is a high altitude area in which human would be exposed in chronic hypoxia environment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is adults who live at Qinghai-Tibet Plateau for Work Purpose.
Key inclusion criteria (4 listed)
- Be provided verbal or written informed consent;
- Men and women ≥ 30 and ≤ 65 years of age;
- Adults living at Qinghai-Tibet Plateau for Work Purpose, and the altitude of residence is more than 2,500 meters;
- Providing electronical or paper medical examination reports which conducted in 2016.
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women;
- Be excluded by Principal investigator for subject's compliance or safety reasons.
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 |
|---|---|---|
| Chronic hypoxic environmentChronic hypoxic environment. Since the partial pressure of oxygen in inspired air falls with increasing terrestrial elevation above sea level, many physiological variables in adults would be affected by the chronic hypoxia environment. | Other | Adults Living at Qinghai-Tibet Plateau for Work Purpose |
Primary outcome
Change in weight from baseline at first year
Time frame: Baseline and 1st year
Change in blood pressure as measured by sphygmomanometer from baseline at first year
Time frame: Baseline and 1st year
The blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.
Change in serum lipid from baseline at first year
Time frame: Baseline and 1st year
Change in blood glucose from baseline at first year
Time frame: Baseline and 1st year
13 secondary outcomes
Change in weight from baseline at second year
Time frame: Baseline and 2nd year
Change in weight from baseline at third year
Time frame: Baseline and 3rd year
Change in blood pressure as measured by sphygmomanometer from baseline at second year
Time frame: Baseline and 2nd year
Change in blood pressure as measured by sphygmomanometer from baseline at third year
Time frame: Baseline and 3rd year
Change in serum lipid from baseline at second year
Time frame: Baseline and 2nd year
Change in serum lipid from baseline at third year
Time frame: Baseline and 3rd year
Change in blood glucose from baseline at second year
Time frame: Baseline and 2nd year
Change in blood glucose from baseline at third year
Time frame: Baseline and 3rd year
Pathological changes from baseline at first year in human body systems
Time frame: Baseline and 1st year
Pathological changes from baseline at second year in human body systems
Time frame: Baseline and 2nd year
Pathological changes from baseline at third year in human body systems
Time frame: Baseline and 3rd year
The incidence rate and severity of chronic mountain sickness (CMS)
Time frame: The 2nd year
The incidence rate and severity of chronic mountain sickness (CMS)
Time frame: The 3rd year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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.
Tonghua Liu, Professor principal investigator
Tibetan Traditional Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness, run by Tibetan Traditional Medical College at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Feb 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tonghua Liu, Professor (+86-13801020306, thliu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight from baseline at first year (time frame: Baseline and 1st year). The study lists 4 primary outcomes in all. 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 27 Feb 2018.