2,3-BisphosphoglycerateRIC-BPGNCT04192578
Effect of RIC on 2,3-BPG in Erythrocyte (RIC-BPG)
A study testing remote ischemic conditioning in people with 2,3-Bisphosphoglycerate, run by Capital Medical University.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- 2,3-Bisphosphoglycerate
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:18-65 years old
- Healthy adults
Who cannot join
- Individuals with various chronic diseases.
- Individuals with various acute diseases.
- Individuals who take any medicines
- Individuals who have taken health supplements for more than 2 weeks.
- individuals with BMI<18.5 or BMI≥24
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- 2,3-Bisphosphoglycerate
- Being tested
- remote ischemic conditioning
- Keywords
- Remote ischemic conditioning, 2,3-Bisphosphoglycerate, Erythrocyte, Oxygen, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningDevice
RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral upper limb 60mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
| Bilateral upper limb 60mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
| Unilateral upper limb 200mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
| Bilateral upper limb 200mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
| Unilateral lower limb 60mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
| Bilateral lower limb 60mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
| Unilateral lower limb 200mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
| Bilateral lower limb 200mmHg RIC | Experimental | 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. Receives: Device: remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of 2,3-BPG levels in erythrocyte
Whole blood for testing effect of RIC on 2,3-BPG in Erythrocyte
Measured: through study completion, an average of 24 hours
Secondary outcomes (7)
Changes of prothrombin time(PT)
Whole blood for testing effect of RIC on PT
Measured: through study completion, an average of 24 hours
Changes of activated partial thromboplastin time(APPT)
Whole blood for testing effect of RIC on APPT
Measured: through study completion, an average of 24 hours
Changes of activated partial thrombin time(TT)
Whole blood for testing effect of RIC on TT
Measured: through study completion, an average of 24 hours
Changes of Fibrinogen(FIB)
Whole blood for testing effect of RIC on FIB
Measured: through study completion, an average of 24 hours
Changes of D-dimer
Whole blood for testing effect of RIC on D-dimer
Measured: through study completion, an average of 24 hours
Changes of hypoxia inducible factor-1(HIF-1)
Whole blood for testing effect of RIC on HIF-1
Measured: through study completion, an average of 24 hours
Changes of lower limbs venous blood flow
Vascular ultrasound for detecting venous blood flow in lower limbs
Measured: through study completion, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Jan 2021 (estimated)
- Primary completion15 Mar 2021 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2,3-BisphosphoglycerateStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192578
- Sponsor's protocol ID
- RIC-2,3-BPG
- Acronym
- RIC-BPG
- Status last verified
- Nov 2020
- First submitted
- 31 Oct 2019
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Conditioning on 2,3-bisphosphoglycerate in Erythrocyte
- ClinicalTrials.gov ID
- NCT04192578
- Acronym / sponsor ID
- RIC-BPG / RIC-2,3-BPG
- Conditions
- 2,3-Bisphosphoglycerate
- Keywords
- Remote ischemic conditioning, 2,3-Bisphosphoglycerate, Erythrocyte, Oxygen, healthy subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Unilateral upper limb 60mmHg RIC | Experimental | Device: remote ischemic conditioningRIC 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 | Experimental | Device: remote ischemic conditioningRIC 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 | Experimental | Device: remote ischemic conditioningRIC 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. |
| Bilateral upper limb 200mmHg RIC | Experimental | Device: remote ischemic conditioningRIC 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 lower limb 60mmHg RIC | Experimental | Device: remote ischemic conditioningRIC 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. |
| Bilateral lower limb 60mmHg RIC | Experimental | Device: remote ischemic conditioningRIC 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. |
| Unilateral lower limb 200mmHg RIC | Experimental | Device: remote ischemic conditioningRIC 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 | Experimental | Device: remote ischemic conditioningRIC 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age:18-65 years old
- Healthy adults
Key exclusion criteria (5 listed)
- Individuals with various chronic diseases.
- Individuals with various acute diseases.
- Individuals who take any medicines
- Individuals who have taken health supplements for more than 2 weeks.
- individuals with BMI<18.5 or BMI≥24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioningRIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently. | Device | Bilateral lower limb 200mmHg RIC, Bilateral lower limb 60mmHg RIC, Bilateral upper limb 200mmHg RIC, Bilateral upper limb 60mmHg RIC, Unilateral lower limb 200mmHg RIC, Unilateral lower limb 60mmHg RIC, Unilateral upper limb 200mmHg RIC, Unilateral upper limb 60mmHg RIC |
Primary outcome
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
7 secondary outcomes
Changes of prothrombin time(PT)
Time frame: 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
Changes of activated partial thrombin time(TT)
Time frame: through study completion, an average of 24 hours
Changes of Fibrinogen(FIB)
Time frame: through study completion, an average of 24 hours
Changes of D-dimer
Time frame: 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
Changes of lower limbs venous blood flow
Time frame: through study completion, an average of 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD, PhD principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic conditioning in people with 2,3-Bisphosphoglycerate, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD, PhD (011-86-10-8319-8952, jixunming@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of 2,3-BPG levels in erythrocyte (time frame: through study completion, an average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.