Clinical trial NCT03446898: A Study of the Effect of High Altitudes on Physiological and Metabolic Markers in Adults Living at Qinghai-Tibet Plateau for Work Purpose
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness
Lead sponsor: Tibetan Traditional Medical College
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: Chengdu University of Traditional Chinese Medicine
First posted: 2018-02-27
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is adults who live at Qinghai-Tibet Plateau for Work Purpose.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in weight from baseline at first year
timeFrame: Baseline and 1st year
measure: Change in blood pressure as measured by sphygmomanometer from baseline at first year
timeFrame: Baseline and 1st year
measure: Change in serum lipid from baseline at first year
timeFrame: Baseline and 1st year
measure: Change in blood glucose from baseline at first year
timeFrame: Baseline and 1st year
Secondary outcomes:
measure: Change in weight from baseline at second year
timeFrame: Baseline and 2nd year
measure: Change in weight from baseline at third year
timeFrame: Baseline and 3rd year
measure: Change in blood pressure as measured by sphygmomanometer from baseline at second year
timeFrame: Baseline and 2nd year
measure: Change in blood pressure as measured by sphygmomanometer from baseline at third year
timeFrame: Baseline and 3rd year
measure: Change in serum lipid from baseline at second year
timeFrame: Baseline and 2nd year
measure: Change in serum lipid from baseline at third year
timeFrame: Baseline and 3rd year
measure: Change in blood glucose from baseline at second year
timeFrame: Baseline and 2nd year
measure: Change in blood glucose from baseline at third year
timeFrame: Baseline and 3rd year
measure: Pathological changes from baseline at first year in human body systems
timeFrame: Baseline and 1st year
measure: Pathological changes from baseline at second year in human body systems
timeFrame: Baseline and 2nd year
measure: Pathological changes from baseline at third year in human body systems
timeFrame: Baseline and 3rd year
measure: The incidence rate and severity of chronic mountain sickness (CMS)
timeFrame: The 2nd year
measure: The incidence rate and severity of chronic mountain sickness (CMS)
timeFrame: The 3rd year
Other outcomes:
measure: Relationship between altitudes and pathological changes in human body under chronic hypoxic environment
timeFrame: Up to the 3rd year
measure: Relationship between age and pathological changes in human body under chronic hypoxic environment
timeFrame: Up to the 3rd year
measure: Relationship between gender and pathological changes in human body under chronic hypoxic environment
timeFrame: Up to the 3rd year
Locations:
city: Lhasa
country: China
facility: Tibetan Traditional Medical College
state: Xizang Autonomous Region
Study officials:
affiliation: Tibetan Traditional Medical College
name: Tonghua Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References: