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

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ClinicalTrials.gov Identifier: NCT03446898
Recruitment Status : Unknown
Verified February 2018 by Tibetan Traditional Medical College.
Recruitment status was:  Recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
Beijing University of Chinese Medicine
Chengdu University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Tibetan Traditional Medical College

Study Description
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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).

Condition or disease Intervention/treatment
Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness 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 Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : July 22, 2017
Estimated Primary Completion Date : March 22, 2018
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in weight from baseline at first year [ Time Frame: Baseline and 1st year ]
  2. Change in blood pressure as measured by sphygmomanometer from baseline at first year [ Time Frame: 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.

  3. Change in serum lipid from baseline at first year [ Time Frame: Baseline and 1st year ]
  4. Change in blood glucose from baseline at first year [ Time Frame: Baseline and 1st year ]

Secondary Outcome Measures :
  1. Change in weight from baseline at second year [ Time Frame: Baseline and 2nd year ]
  2. Change in weight from baseline at third year [ Time Frame: Baseline and 3rd year ]
  3. Change in blood pressure as measured by sphygmomanometer from baseline at second year [ Time Frame: 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.

  4. Change in blood pressure as measured by sphygmomanometer from baseline at third year [ Time Frame: 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.

  5. Change in serum lipid from baseline at second year [ Time Frame: Baseline and 2nd year ]
  6. Change in serum lipid from baseline at third year [ Time Frame: Baseline and 3rd year ]
  7. Change in blood glucose from baseline at second year [ Time Frame: Baseline and 2nd year ]
  8. Change in blood glucose from baseline at third year [ Time Frame: Baseline and 3rd year ]
  9. Pathological changes from baseline at first year in human body systems [ Time Frame: Baseline and 1st year ]
  10. Pathological changes from baseline at second year in human body systems [ Time Frame: Baseline and 2nd year ]
  11. Pathological changes from baseline at third year in human body systems [ Time Frame: Baseline and 3rd year ]
  12. The incidence rate and severity of chronic mountain sickness (CMS) [ Time Frame: The 2nd 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.

  13. The incidence rate and severity of chronic mountain sickness (CMS) [ Time Frame: 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.


Other Outcome Measures:
  1. Relationship between altitudes and pathological changes in human body under chronic hypoxic environment [ Time Frame: Up to the 3rd year ]
  2. Relationship between age and pathological changes in human body under chronic hypoxic environment [ Time Frame: Up to the 3rd year ]
  3. Relationship between gender and pathological changes in human body under chronic hypoxic environment [ Time Frame: Up to the 3rd year ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population is adults who live at Qinghai-Tibet Plateau for Work Purpose.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446898


Contacts
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Contact: Tonghua Liu, Professor +86-13801020306 thliu@vip.163.com
Contact: Yingchun He, Master +86-13880930756 17190782@qq.com

Locations
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China, Xizang Autonomous Region
Tibetan Traditional Medical College Recruiting
Lhasa, Xizang Autonomous Region, China
Contact: Yingchun He, Master    +86-13880930756    17190782@qq.com   
Contact: Tonghua Liu, Professor    +86-13801020306    thliu@vip.163.com   
Sponsors and Collaborators
Tibetan Traditional Medical College
Beijing University of Chinese Medicine
Chengdu University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Tonghua Liu, Professor Tibetan Traditional Medical College
More Information
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Responsible Party: Tibetan Traditional Medical College
ClinicalTrials.gov Identifier: NCT03446898    
Other Study ID Numbers: Z2016B01G03/02-CRP
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases