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

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

• Registration Number: NCT03446898
• Lead Sponsor: Tibetan Traditional Medical College

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.

Study Timeline

• Study Start: 2017-07-22
• Study First Submitted: 2018-01-30
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-23
• Last Update Submitted: 2018-02-23
• Study First Posted: 2018-02-27
• Last Update Posted: 2018-02-27
• Primary Completion: 2018-03-22
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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	Baseline and 1st year
Change in blood glucose from baseline at first year	Baseline and 1st year

Secondary Outcome Measures

Name	Time	Method
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	Baseline and 2nd year	The blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.
Change in blood pressure as measured by sphygmomanometer from baseline at third year	Baseline and 3rd 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 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 3rd year	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.

Trial Locations

Locations (1)

Tibetan Traditional Medical College; 🇨🇳 Lhasa, Xizang Autonomous Region, China