Effect of RIC on 2,3-BPG in Erythrocyte (RIC-BPG)

2,3-Bisphosphoglycerate Clinical Trial

— RIC-BPG  

Official title:

The Effect of Remote Ischemic Conditioning on 2,3-bisphosphoglycerate in Erythrocyte

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04192578
• Other study ID #: RIC-2,3-BPG
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: March 15, 2021

Study information

• Verified date: November 2020
• Source: Capital Medical University
• Contact: Xunming Ji, MD, PhD
• Phone: 011-86-10-8319-8952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• 2,3-Bisphosphoglycerate

Intervention

Device:
• remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of 2,3-BPG levels in erythrocyte	Whole blood for testing effect of RIC on 2,3-BPG in Erythrocyte	through study completion, an average of 24 hours
Secondary	Changes of prothrombin time(PT)	Whole blood for testing effect of RIC on PT	through study completion, an average of 24 hours
Secondary	Changes of activated partial thromboplastin time(APPT)	Whole blood for testing effect of RIC on APPT	through study completion, an average of 24 hours
Secondary	Changes of activated partial thrombin time(TT)	Whole blood for testing effect of RIC on TT	through study completion, an average of 24 hours
Secondary	Changes of Fibrinogen(FIB)	Whole blood for testing effect of RIC on FIB	through study completion, an average of 24 hours
Secondary	Changes of D-dimer	Whole blood for testing effect of RIC on D-dimer	through study completion, an average of 24 hours
Secondary	Changes of hypoxia inducible factor-1(HIF-1)	Whole blood for testing effect of RIC on HIF-1	through study completion, an average of 24 hours
Secondary	Changes of lower limbs venous blood flow	Vascular ultrasound for detecting venous blood flow in lower limbs	through study completion, an average of 24 hours