Clinical trial NCT04192578: Effect of RIC on 2,3-BPG in Erythrocyte (RIC-BPG)
Official title: The Effect of Remote Ischemic Conditioning on 2,3-bisphosphoglycerate in Erythrocyte
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 2,3-Bisphosphoglycerate
Keywords: Remote ischemic conditioning
2,3-Bisphosphoglycerate
Erythrocyte
Oxygen
healthy subjects
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Under hypoxia or high-altitude hypoxia ,it has been found that 2,3-bisphosphoglycerate(2,3-BPG) in erythrocyte increased and facilitated oxygen release to tissues.Remote Ischemic Conditioning(RIC) can also cause hypoxic conditions in local limbs.Thus,we hypothesize that whether RIC could also increase 2,3-BPG in erythrocyte.

Detailed description: RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently and has been proved to be effective in ischemic stroke and myocardial infarction(MI).The possible mechanisms of RIC protection is complicated.RIC leads to local ischemia and hypoxia and has been demonstrated to play a role in vital organs through hypoxia inducible factors(HIF) against stroke and MI.Besides HIF, hypoxia or high-altitude hypoxia could also change glycolytic process in erythrocyte through adenosine or sphingosine-1-phosphate(S1P).Accompanying with alternating glucolysis, 2,3-diphosphoglycerate(2,3-BPG) in erythrocyte increases and it also facilitating oxygen release to tissues.Thus,we hypothesize that whether RIC could also increase 2,3-BPG in erythrocyte.There are 8 arms in this trial: All arms are RIC treatment. The level of 2,3-BPG in erythrocyte will be assessed by ELISA before and after the treatment.

Eligibility criteria: Inclusion Criteria:

1. Age:18-65 years old
2. Healthy adults

Exclusion Criteria:

1. Individuals with various chronic diseases.
2. Individuals with various acute diseases.
3. Individuals who take any medicines
4. Individuals who have taken health supplements for more than 2 weeks.
5. individuals with BMI\<18.5 or BMI≥24

Primary outcomes:
measure: Changes of 2,3-BPG levels in erythrocyte
timeFrame: through study completion, an average of 24 hours
Secondary outcomes:
measure: Changes of prothrombin time(PT)
timeFrame: through study completion, an average of 24 hours
measure: Changes of activated partial thromboplastin time(APPT)
timeFrame: through study completion, an average of 24 hours
measure: Changes of activated partial thrombin time(TT)
timeFrame: through study completion, an average of 24 hours
measure: Changes of Fibrinogen(FIB)
timeFrame: through study completion, an average of 24 hours
measure: Changes of D-dimer
timeFrame: through study completion, an average of 24 hours
measure: Changes of hypoxia inducible factor-1(HIF-1)
timeFrame: through study completion, an average of 24 hours
measure: Changes of lower limbs venous blood flow
timeFrame: through study completion, an average of 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: