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Status unknownNCT04192578RIC-BPGUpdated Dec 1, 2020

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

An interventional study of remote ischemic conditioning in 2,3-Bisphosphoglycerate, sponsored by Capital Medical University. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-01.

Sponsored by Capital Medical University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 2,3-Bisphosphoglycerate

Keywords

  • Remote ischemic conditioning
  • 2,3-Bisphosphoglycerate
  • Erythrocyte
  • Oxygen
  • healthy subjects
03

In context

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Deviceremote ischemic conditioning

    RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.

06

What researchers measure

Primary outcomes

  1. Changes of 2,3-BPG levels in erythrocyte

    Whole blood for testing effect of RIC on 2,3-BPG in Erythrocyte

    Time frame: through study completion, an average of 24 hours

Secondary outcomes

  1. Changes of prothrombin time(PT)

    Whole blood for testing effect of RIC on PT

    Time frame: through study completion, an average of 24 hours

  2. Changes of activated partial thromboplastin time(APPT)

    Whole blood for testing effect of RIC on APPT

    Time frame: through study completion, an average of 24 hours

  3. Changes of activated partial thrombin time(TT)

    Whole blood for testing effect of RIC on TT

    Time frame: through study completion, an average of 24 hours

  4. Changes of Fibrinogen(FIB)

    Whole blood for testing effect of RIC on FIB

    Time frame: through study completion, an average of 24 hours

  5. Changes of D-dimer

    Whole blood for testing effect of RIC on D-dimer

    Time frame: through study completion, an average of 24 hours

  6. Changes of hypoxia inducible factor-1(HIF-1)

    Whole blood for testing effect of RIC on HIF-1

    Time frame: through study completion, an average of 24 hours

  7. Changes of lower limbs venous blood flow

    Vascular ultrasound for detecting venous blood flow in lower limbs

    Time frame: through study completion, an average of 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04192578
Lead sponsor
Capital Medical University
Responsible party
Ji Xunming,MD,PhD (Professor, Capital Medical University) — Principal investigator
First posted
Dec 10, 2019
Start date
Jan 15, 2021 (estimated)
Primary completion
Mar 15, 2021 (estimated)
Completion
Mar 15, 2021 (estimated)
Last update
Dec 1, 2020

Study contacts

Xunming Ji, MD, PhD
Contact
jixunming@vip.163.com
011-86-10-8319-8952
Lin Wang
Contact
13020025628@163.com
861013020025628
Xunming Ji, MD, PhD
principal investigator · Xuanwu Hospital, Beijing

Oversight

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

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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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