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

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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03446898
• Other study ID #: Z2016B01G03/02-CRP
• Status: Recruiting
• Phase: N/A
• First received: January 30, 2018
• Last updated: February 23, 2018
• Start date: July 22, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2018
• Source: Tibetan Traditional Medical College
• Contact: Tonghua Liu, Professor
• Phone: +86-13801020306
• Email: thliu[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 1, 2019
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Chronic 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.

Locations

Country	Name	City	State
China	Tibetan Traditional Medical College	Lhasa	Xizang Autonomous Region

Sponsors (3)

Lead Sponsor	Collaborator
Tibetan Traditional Medical College	Beijing University of Chinese Medicine, Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between altitudes and pathological changes in human body under chronic hypoxic environment		Up to the 3rd year
Other	Relationship between age and pathological changes in human body under chronic hypoxic environment		Up to the 3rd year
Other	Relationship between gender and pathological changes in human body under chronic hypoxic environment		Up to the 3rd year
Primary	Change in weight from baseline at first year		Baseline and 1st year
Primary	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
Primary	Change in serum lipid from baseline at first year		Baseline and 1st year
Primary	Change in blood glucose from baseline at first year		Baseline and 1st year
Secondary	Change in weight from baseline at second year		Baseline and 2nd year
Secondary	Change in weight from baseline at third year		Baseline and 3rd year
Secondary	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
Secondary	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
Secondary	Change in serum lipid from baseline at second year		Baseline and 2nd year
Secondary	Change in serum lipid from baseline at third year		Baseline and 3rd year
Secondary	Change in blood glucose from baseline at second year		Baseline and 2nd year
Secondary	Change in blood glucose from baseline at third year		Baseline and 3rd year
Secondary	Pathological changes from baseline at first year in human body systems		Baseline and 1st year
Secondary	Pathological changes from baseline at second year in human body systems		Baseline and 2nd year
Secondary	Pathological changes from baseline at third year in human body systems		Baseline and 3rd year
Secondary	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
Secondary	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