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

Not Applicable

• Conditions: 2,3-Bisphosphoglycerate
• Interventions: Device: remote ischemic conditioning

• Registration Number: NCT04192578
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-29
• Last Update Posted: 2020-12-01
• Study Start: 2021-01-15
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral lower limb 60mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral lower limb and inflated to 60 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Bilateral upper limb 200mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral upper limb and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Unilateral upper limb 60mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral upper limb and inflated to 60 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Bilateral upper limb 60mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral upper limb and inflated to 60 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Unilateral upper limb 200mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral upper limb and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Unilateral lower limb 60mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral lower limb and inflated to 60 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Unilateral lower limb 200mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral lower limb and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Bilateral lower limb 200mmHg RIC	remote ischemic conditioning	RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral lower limb and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.

Primary Outcome Measures

Name	Time	Method
Changes of 2,3-BPG levels in erythrocyte	through study completion, an average of 24 hours	Whole blood for testing effect of RIC on 2,3-BPG in Erythrocyte

Secondary Outcome Measures

Name	Time	Method
Changes of hypoxia inducible factor-1(HIF-1)	through study completion, an average of 24 hours	Whole blood for testing effect of RIC on HIF-1
Changes of activated partial thrombin time(TT)	through study completion, an average of 24 hours	Whole blood for testing effect of RIC on TT
Changes of lower limbs venous blood flow	through study completion, an average of 24 hours	Vascular ultrasound for detecting venous blood flow in lower limbs
Changes of D-dimer	through study completion, an average of 24 hours	Whole blood for testing effect of RIC on D-dimer
Changes of activated partial thromboplastin time(APPT)	through study completion, an average of 24 hours	Whole blood for testing effect of RIC on APPT
Changes of prothrombin time(PT)	through study completion, an average of 24 hours	Whole blood for testing effect of RIC on PT
Changes of Fibrinogen(FIB)	through study completion, an average of 24 hours	Whole blood for testing effect of RIC on FIB