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A Study of the Effect of High Altitudes on Physiological and Metabolic Markers in Adults Living at Qinghai-Tibet Plateau for Work Purpose

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03446898
Enrollment
160
Registered
2018-02-27
Start date
2017-07-22
Completion date
2019-07-01
Last updated
2018-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness

Brief 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).

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.

Interventions

OTHERChronic hypoxic environment

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.

Sponsors

Beijing University of Chinese Medicine
CollaboratorOTHER
Chengdu University of Traditional Chinese Medicine
CollaboratorOTHER
Tibetan Traditional Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Pregnant or breast-feeding women; * Be excluded by Principal investigator for subject's compliance or safety reasons.

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressure as measured by sphygmomanometer from baseline at first yearBaseline and 1st yearThe blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.
Change in blood glucose from baseline at first yearBaseline and 1st year
Change in serum lipid from baseline at first yearBaseline and 1st year
Change in weight from baseline at first yearBaseline and 1st year

Secondary

MeasureTime frameDescription
Change in blood pressure as measured by sphygmomanometer from baseline at third yearBaseline and 3rd yearThe 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 second yearBaseline and 2nd year
Change in serum lipid from baseline at third yearBaseline and 3rd year
Change in blood glucose from baseline at third yearBaseline and 3rd year
Pathological changes from baseline at first year in human body systemsBaseline and 1st year
Pathological changes from baseline at second year in human body systemsBaseline and 2nd year
Pathological changes from baseline at third year in human body systemsBaseline and 3rd year
The incidence rate and severity of chronic mountain sickness (CMS)The 2nd yearThe 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.
Change in blood glucose from baseline at second yearBaseline and 2nd year
Change in weight from baseline at second yearBaseline and 2nd year
Change in weight from baseline at third yearBaseline and 3rd year
Change in blood pressure as measured by sphygmomanometer from baseline at second yearBaseline and 2nd yearThe blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.

Other

MeasureTime frame
Relationship between altitudes and pathological changes in human body under chronic hypoxic environmentUp to the 3rd year
Relationship between gender and pathological changes in human body under chronic hypoxic environmentUp to the 3rd year
Relationship between age and pathological changes in human body under chronic hypoxic environmentUp to the 3rd year

Countries

China

Contacts

Primary ContactTonghua Liu, Professor
thliu@vip.163.com+86-13801020306
Backup ContactYingchun He, Master
17190782@qq.com+86-13880930756

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026