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Status unknownNCT03446898Updated Feb 27, 2018

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

An observational study in Residence or Prolonged Visit at High Altitude as the Cause of Mountain Sickness, sponsored by Tibetan Traditional Medical College. Status unknown at 1 site in China. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by Tibetan Traditional Medical College · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
160
Ages
30 Years to 65 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

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

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03

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • Pregnant or breast-feeding women;
  • Be excluded by Principal investigator for subject's compliance or safety reasons.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherChronic 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.

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What researchers measure

Primary outcomes

  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

    The blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.

    Time frame: Baseline and 1st year

  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 outcomes

  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

    The blood pressure will be described in the format of diastolic pressure/systolic pressure, and the unit of measure is mmHg.

    Time frame: Baseline and 2nd year

  4. 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.

    Time frame: Baseline and 3rd year

  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)

    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.

    Time frame: The 2nd year

  13. 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.

    Time frame: The 3rd year

Other outcomes

  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

06

Study locations

1 of 1 sites recruiting
  • Tibetan Traditional Medical College
    Lhasa, Xizang Autonomous Region, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03446898
Lead sponsor
Tibetan Traditional Medical College
Collaborators
Beijing University of Chinese Medicine, Chengdu University of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Jul 22, 2017
Primary completion
Mar 22, 2018 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Feb 27, 2018

Study contacts

Tonghua Liu, Professor
Contact
thliu@vip.163.com
+86-13801020306
Yingchun He, Master
Contact
17190782@qq.com
+86-13880930756
Tonghua Liu, Professor
principal investigator · Tibetan Traditional Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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