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

NCT04192578 | Unknown

• 1 other identifier: RIC-2,3-BPG
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

2,3-Bisphosphoglycerate

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes of prothrombin time(PT)

  through study completion, an average of 24 hours

• Changes of activated partial thromboplastin time(APPT)

  through study completion, an average of 24 hours

• Changes of activated partial thrombin time(TT)

  through study completion, an average of 24 hours

• Changes of Fibrinogen(FIB)

  through study completion, an average of 24 hours

• Changes of D-dimer

  through study completion, an average of 24 hours

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Device: remote ischemic conditioning

Interventions

remote ischemic conditioning DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18-65 years old
• Healthy adults

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Officials

• Xunming Ji, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD, PhD

CONTACT

011-86-10-8319-8952; jixunming@vip.163.com

Lin Wang

CONTACT

861013020025628; 13020025628@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: December 10, 2019
• Study Start: January 15, 2021
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: December 1, 2020

Record last verified: 2020-11