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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: Chronic hypoxic environment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults Living at Qinghai-Tibet Plateau for Work Purpose<br>Qinghai-Tibet Plateau is a high altitude area in which human would be exposed in chronic hypoxia environment. | Other: Chronic hypoxic environment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline at first year |  | 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. | Baseline and 1st year | 
| Change in serum lipid from baseline at first year |  | Baseline and 1st year | 
| Change in blood glucose from baseline at first year |  | Baseline and 1st year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline at second year |  | Baseline and 2nd year | 
| Change in weight from baseline at third year |  | 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. | 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. | Baseline and 3rd year | 
| Change in serum lipid from baseline at second year |  | Baseline and 2nd year | 
| Change in serum lipid from baseline at third year |  | Baseline and 3rd year | 
| Change in blood glucose from baseline at second year |  | Baseline and 2nd year | 
| Change in blood glucose from baseline at third year |  | Baseline and 3rd year | 
| Pathological changes from baseline at first year in human body systems |  | Baseline and 1st year | 
| Pathological changes from baseline at second year in human body systems |  | Baseline and 2nd year | 
| Pathological changes from baseline at third year in human body systems |  | 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. | 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. | The 3rd year |