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

November 29, 2020 updated by: Ji Xunming,MD,PhD, Capital Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unilateral upper limb 60mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
Experimental: Bilateral upper limb 60mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
Experimental: Unilateral upper limb 200mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
Experimental: Bilateral upper limb 200mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
Experimental: Unilateral lower limb 60mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
Experimental: Bilateral lower limb 60mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
Experimental: Unilateral lower limb 200mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
Experimental: Bilateral lower limb 200mmHg RIC
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.
Device: remote ischemic conditioning
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of 2,3-BPG levels in erythrocyte
Time Frame: through study completion, an average of 24 hours
Whole blood for testing effect of RIC on 2,3-BPG in Erythrocyte
through study completion, an average of 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Principal Investigator: Xunming Ji, MD, PhD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2021

Primary Completion (Anticipated)

March 15, 2021

Study Completion (Anticipated)

March 15, 2021

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 29, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RIC-2,3-BPG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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