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Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury (AURORAS)

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ClinicalTrials.gov Identifier: NCT02255006
Recruitment Status : Unknown
Verified May 2014 by Weon Kim, Kyunghee University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Weon Kim, Kyunghee University Medical Center

Brief Summary:

Some studies suggest that acupuncture improve flow mediated dilation (FMD) that represents endothelial function, but no study has investigated whether acupuncture protects against ischemia and reperfusion (IR)-induced endothelial dysfunction in humans.

This is a prospective crossover study clinical trial. In the first crossover study, 20 healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture or control. Endothelium-dependent, FMD of the brachial artery will be measured before and after IR (15 minutes of ischemia at the level of the proximal upper arm followed by 15 minutes of reperfusion). Acupuncture will be performed from 10 minute after ischemia till the end time of reperfusion for 20 minutes. In the second single arm study, 16 volunteers are administered oral 5mg glibenclamide two hours before IR injury (n=8) or selective cox-2 inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for acupuncture effect on IR injury. FMD measurements and acupuncture intervention during IR injury are same as above mentioned.


Condition or disease Intervention/treatment Phase
Healthy Device: Active acupuncture Device: Sham acupuncture Drug: Euglucon 5mg Drug: Celebrex 200mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury Via Adenosine Triphosphate-sensitive Potassium Channels or Prostaglandin Pathway
Study Start Date : May 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: active acupuncture
The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.
Device: Active acupuncture
Active acupuncture treatment group receive electroacupuncture (EA). For EA treatment, unilateral acupuncture meridian point Pericardium5 (PC5), Pericardium6 (PC6), Stomach36 (ST36), and Stomach37 (ST37) are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2 Hertz continuous wave current. After FMD measurement, a pneumatic cuff placed above the upper arms is inflated to 200 mmHg for 15 minutes. The cuff is then deflated, and 15 minutes of reperfusion is allowed before FMD measurement again. Acupuncture is performed from after ten minutes of ischemia till end time of reperfusion

Drug: Euglucon 5mg
8 healthy volunteers are administered 5 mg of glibenclamide (Euglucon, Roche Pharma) 3 hour before FMD measurement. This dosage has previously been shown to be able to completely inhibit forearm KATP channels. With the glibenclamide administration, a 10% dextrose infusion is started and titrated to maintain blood sugar levels between 80 and 120 mg/dL throughout the study period. 3 hours after glibenclamide administration, the subjects undergo FMD measurement before and after ischemia reperfusion injury. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method.
Other Name: Glibenclamide

Drug: Celebrex 200mg
8 healthy volunteers are administered celecoxib, a selective COX-2 inhibitor, 200 mg twice daily for 5 days. Last dose of celecoxib is administered at morning. Volunteers undergo FMD measurements before and after ischemia reperfusion injury in that morning of last dose of celecoxib. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method
Other Name: Celecoxib

Sham Comparator: Sham acupuncture
The participants in this group receive sham acupuncture treatment at first. afterwards crossover study is scheduled to be performed
Device: Sham acupuncture

For sham intervention, nonacupuncture points are used. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.

Volunteers undergo FMD measurement and acupuncture like above methods.


Experimental: Euglycon
Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.
Device: Active acupuncture
Active acupuncture treatment group receive electroacupuncture (EA). For EA treatment, unilateral acupuncture meridian point Pericardium5 (PC5), Pericardium6 (PC6), Stomach36 (ST36), and Stomach37 (ST37) are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2 Hertz continuous wave current. After FMD measurement, a pneumatic cuff placed above the upper arms is inflated to 200 mmHg for 15 minutes. The cuff is then deflated, and 15 minutes of reperfusion is allowed before FMD measurement again. Acupuncture is performed from after ten minutes of ischemia till end time of reperfusion

Drug: Euglucon 5mg
8 healthy volunteers are administered 5 mg of glibenclamide (Euglucon, Roche Pharma) 3 hour before FMD measurement. This dosage has previously been shown to be able to completely inhibit forearm KATP channels. With the glibenclamide administration, a 10% dextrose infusion is started and titrated to maintain blood sugar levels between 80 and 120 mg/dL throughout the study period. 3 hours after glibenclamide administration, the subjects undergo FMD measurement before and after ischemia reperfusion injury. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method.
Other Name: Glibenclamide

Experimental: Celebrex
Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.
Device: Active acupuncture
Active acupuncture treatment group receive electroacupuncture (EA). For EA treatment, unilateral acupuncture meridian point Pericardium5 (PC5), Pericardium6 (PC6), Stomach36 (ST36), and Stomach37 (ST37) are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2 Hertz continuous wave current. After FMD measurement, a pneumatic cuff placed above the upper arms is inflated to 200 mmHg for 15 minutes. The cuff is then deflated, and 15 minutes of reperfusion is allowed before FMD measurement again. Acupuncture is performed from after ten minutes of ischemia till end time of reperfusion

Drug: Celebrex 200mg
8 healthy volunteers are administered celecoxib, a selective COX-2 inhibitor, 200 mg twice daily for 5 days. Last dose of celecoxib is administered at morning. Volunteers undergo FMD measurements before and after ischemia reperfusion injury in that morning of last dose of celecoxib. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method
Other Name: Celecoxib




Primary Outcome Measures :
  1. The difference of endothelial function [ Time Frame: 4 week ]
    Endothelial function is measured by brachial flow mediated dilation (FMD). Is there a difference of forearm FMD achieved following ischemia reperfusion injury between acupuncture and control group


Secondary Outcome Measures :
  1. The difference of endothelial function [ Time Frame: 4 week ]
    Endothelial function is also measured by brachial flow mediated dilation (FMD). Is the difference of endothelial function mediated by acupuncture hampered by Triphosphate-Sensitive Potassium (KATP) Channels inhibitor glibenclamide or selective cox-2 inhibitor celebrex if acupuncture could improve flow mediated dilation after ischemia reperfusion injury? It is performed for knowing which mechanisms are involved in this improvement if acupuncture could improve flow mediated dilation after ischemia reperfusion injury?



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer age 25 to 40 years
  • non-smoker

Exclusion Criteria:

  • hypertension (>140/90 mmHg), diabetes any cardiovascular disease kidney disease thyroid disease cerebrovascular disease liver disease (bilirubin level >2 mg/dl) pregnancy body mass index >25 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255006


Contacts
Contact: Weon Kim, Professor 82-2-958-8176 mylovekw@hanmail.net

Locations
Korea, Republic of
Kyung Hee University Medical Center Recruiting
Seoul, Korea, Republic of, 130-701
Contact: Weon Kim, Professor    82-2-958-8176    mylovekw@hanmail.net   
Sponsors and Collaborators
Kyunghee University Medical Center
Ministry of Health & Welfare, Korea
Investigators
Principal Investigator: Weon Kim Kyunghee University Medical Center

Responsible Party: Weon Kim, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02255006     History of Changes
Other Study ID Numbers: HI13C0580-2
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: May 2014

Keywords provided by Weon Kim, Kyunghee University Medical Center:
volunteer
BMI(25 kg/m2)

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Celecoxib
Glyburide
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Hypoglycemic Agents