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

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).

Study Overview

• Status: Unknown
• Conditions: Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness
• Intervention / Treatment: Other: Chronic hypoxic environment

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Tonghua Liu, Professor; Phone Number: +86-13801020306; Email: thliu@vip.163.com
• Study Contact Backup: Name: Yingchun He, Master; Phone Number: +86-13880930756; Email: 17190782@qq.com

Study Locations

• China
  • Xizang Autonomous Region
    • Lhasa, Xizang Autonomous Region, China
      • Recruiting
      • Tibetan Traditional Medical College
      • Contact: Tonghua Liu, Professor; Phone Number: +86-13801020306; Email: thliu@vip.163.com
      • Contact: Yingchun He, Master; Phone Number: +86-13880930756; Email: 17190782@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is adults who live at Qinghai-Tibet Plateau for Work Purpose.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults Living at Qinghai-Tibet Plateau for Work Purpose; Qinghai-Tibet Plateau is a high altitude area in which human would be exposed in chronic hypoxia environment.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Relationship between altitudes and pathological changes in human body under chronic hypoxic environment	Up to the 3rd year
Relationship between age and pathological changes in human body under chronic hypoxic environment	Up to the 3rd year
Relationship between gender and pathological changes in human body under chronic hypoxic environment	Up to the 3rd year

Collaborators and Investigators

• Sponsor: Tibetan Traditional Medical College
• Collaborators: Chengdu University of Traditional Chinese Medicine; Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Tonghua Liu, Professor, Tibetan Traditional Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2017
• Primary Completion (Anticipated): March 22, 2018
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: Z2016B01G03/02-CRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No