HealthyAURORASNCT02255006
Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury
A study testing Active acupuncture, Euglucon 5mg and Celebrex 200mg in people with Healthy, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active acupuncture, Euglucon 5mg and Celebrex 200mg
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2014
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer age 25 to 40 years
- non-smoker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Medical Center
Seoul, 130-701
Weon Kim, Professor, 82-2-958-8176, mylovekw@hanmail.net
About this study
Official title: Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury Via Adenosine Triphosphate-sensitive Potassium Channels or Prostaglandin Pathway
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
- Being tested
- Active acupuncture, Sham acupuncture, Euglucon 5mg, Celebrex 200mg
- Keywords
- volunteer, BMI(25 kg/m2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active acupunctureDevice
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
Sham acupunctureDevice
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.
Euglucon 5mgDrug
Also called Glibenclamide
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.
Celebrex 200mgDrug
Also called Celecoxib
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
| Study group | Role | What they receive |
|---|---|---|
| active acupuncture | Experimental | The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed. Receives: 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 Receives: Device: Sham acupuncture |
| Euglycon | Experimental | Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement. Receives: Device: Active acupuncture; Drug: Euglucon 5mg |
| Celebrex | Experimental | Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement. Receives: Device: Active acupuncture; Drug: Celebrex 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 week
Secondary outcomes (1)
The difference of endothelial function
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?
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Weon Kim, Kyunghee University Medical Center
- Investigators
- Weon Kim, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255006
- Sponsor's protocol ID
- HI13C0580-2
- Acronym
- AURORAS
- Status last verified
- May 2014
- First submitted
- 5 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury Via Adenosine Triphosphate-sensitive Potassium Channels or Prostaglandin Pathway
- ClinicalTrials.gov ID
- NCT02255006
- Acronym / sponsor ID
- AURORAS / HI13C0580-2
- Conditions
- Healthy
- Keywords
- volunteer, BMI(25 kg/m2)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- May 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 Oct 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active acupuncture | Experimental | Device: Active acupuncture, Drug: Euglucon 5mg, Drug: Celebrex 200mgThe participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed. |
| Sham acupuncture | Sham comparator | Device: Sham acupunctureThe participants in this group receive sham acupuncture treatment at first. afterwards crossover study is scheduled to be performed |
| Euglycon | Experimental | Device: Active acupuncture, Drug: Euglucon 5mgGlibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement. |
| Celebrex | Experimental | Device: Active acupuncture, Drug: Celebrex 200mgCelebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteer age 25 to 40 years
- non-smoker
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Active acupunctureActive 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 | Device | Celebrex, Euglycon, active acupuncture |
| Sham acupunctureFor 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. | Device | Sham acupuncture |
| Euglucon 5mgAlso: Glibenclamide8 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. | Drug | Euglycon, active acupuncture |
| Celebrex 200mgAlso: Celecoxib8 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 | Drug | Celebrex, active acupuncture |
Primary outcome
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
1 secondary outcome
The difference of endothelial function
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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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.
Weon Kim principal investigator
Kyunghee University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active acupuncture, Euglucon 5mg and Celebrex 200mg in people with Healthy, run by Kyunghee University Medical Center at 1 site in South Korea.
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 1 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Weon Kim, Professor (82-2-958-8176, mylovekw@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of endothelial function (time frame: 4 week). 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 2 Oct 2014.