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

NCT02255006 | Unknown DMC

• 1 other identifier: HI13C0580-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

volunteer; BMI(25 kg/m2)

Outcome Measures

Primary Outcomes (1)

• The difference of endothelial function

  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

  4 week

Secondary Outcomes (1)

• The difference of endothelial function

  4 week

Study Arms (4)

active acupuncture

EXPERIMENTAL

The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.

Device: Active acupuncture; Drug: Euglucon 5mg; Drug: Celebrex 200mg

Sham acupuncture

SHAM COMPARATOR

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

Device: Sham acupuncture

Euglycon

EXPERIMENTAL

Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.

Device: Active acupuncture; Drug: Euglucon 5mg

Celebrex

EXPERIMENTAL

Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.

Device: Active acupuncture; Drug: Celebrex 200mg

Interventions

Active acupuncture DEVICE

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

Celebrex; Euglycon; active acupuncture

Sham acupuncture DEVICE

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.

Sham acupuncture

Euglucon 5mg DRUG

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.

Also known as: Glibenclamide

Euglycon; active acupuncture

Celebrex 200mg DRUG

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

Also known as: Celecoxib

Celebrex; active acupuncture

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (1)

Kyung Hee University Medical Center

Seoul, 130-701, South Korea

RECRUITING

MeSH Terms

Interventions

Glyburide; Celecoxib

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Weon Kim

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weon Kim, Professor

CONTACT

82-2-958-8176; mylovekw@hanmail.net

Study Design

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

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: October 2, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-05

Locations

KR (1)