<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255006</url>
  </required_header>
  <id_info>
    <org_study_id>HI13C0580-2</org_study_id>
    <nct_id>NCT02255006</nct_id>
  </id_info>
  <brief_title>Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury</brief_title>
  <acronym>AURORAS</acronym>
  <official_title>Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury Via Adenosine Triphosphate-sensitive Potassium Channels or Prostaglandin Pathway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyunghee University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health &amp; Welfare, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyunghee University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some studies suggest that acupuncture improve flow mediated dilation (FMD) that represents&#xD;
      endothelial function, but no study has investigated whether acupuncture protects against&#xD;
      ischemia and reperfusion (IR)-induced endothelial dysfunction in humans.&#xD;
&#xD;
      This is a prospective crossover study clinical trial. In the first crossover study, 20&#xD;
      healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture&#xD;
      or control. Endothelium-dependent, FMD of the brachial artery will be measured before and&#xD;
      after IR (15 minutes of ischemia at the level of the proximal upper arm followed by 15&#xD;
      minutes of reperfusion). Acupuncture will be performed from 10 minute after ischemia till the&#xD;
      end time of reperfusion for 20 minutes. In the second single arm study, 16 volunteers are&#xD;
      administered oral 5mg glibenclamide two hours before IR injury (n=8) or selective cox-2&#xD;
      inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for&#xD;
      acupuncture effect on IR injury. FMD measurements and acupuncture intervention during IR&#xD;
      injury are same as above mentioned.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of endothelial function</measure>
    <time_frame>4 week</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference of endothelial function</measure>
    <time_frame>4 week</time_frame>
    <description>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?</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>active acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The participants in this group receive sham acupuncture treatment at first. afterwards crossover study is scheduled to be performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Euglycon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Celebrex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active acupuncture</intervention_name>
    <description>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</description>
    <arm_group_label>Celebrex</arm_group_label>
    <arm_group_label>Euglycon</arm_group_label>
    <arm_group_label>active acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham acupuncture</intervention_name>
    <description>For sham intervention, nonacupuncture points are used. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.&#xD;
Volunteers undergo FMD measurement and acupuncture like above methods.</description>
    <arm_group_label>Sham acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Euglucon 5mg</intervention_name>
    <description>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.</description>
    <arm_group_label>Euglycon</arm_group_label>
    <arm_group_label>active acupuncture</arm_group_label>
    <other_name>Glibenclamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celebrex 200mg</intervention_name>
    <description>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</description>
    <arm_group_label>Celebrex</arm_group_label>
    <arm_group_label>active acupuncture</arm_group_label>
    <other_name>Celecoxib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteer age 25 to 40 years&#xD;
&#xD;
          -  non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension (&gt;140/90 mmHg), diabetes any cardiovascular disease kidney disease&#xD;
             thyroid disease cerebrovascular disease liver disease (bilirubin level &gt;2 mg/dl)&#xD;
             pregnancy body mass index &gt;25 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weon Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyunghee University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weon Kim, Professor</last_name>
    <phone>82-2-958-8176</phone>
    <email>mylovekw@hanmail.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kyung Hee University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>130-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weon Kim, Professor</last_name>
      <phone>82-2-958-8176</phone>
      <email>mylovekw@hanmail.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University Medical Center</investigator_affiliation>
    <investigator_full_name>Weon Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>volunteer</keyword>
  <keyword>BMI(25 kg/m2)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reperfusion Injury</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glyburide</mesh_term>
    <mesh_term>Celecoxib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255006
org study id: HI13C0580-2
nct id: NCT02255006
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The difference of endothelial function
time frame: 4 week
description: 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
measure: The difference of endothelial function
time frame: 4 week
description: 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?
arm group label: active acupuncture
arm group type: Experimental
description: The participants in this group receive real acupuncture treatment at first. Afterwards crossover study is scheduled to be performed.
arm group label: Sham acupuncture
arm group type: Sham Comparator
description: The participants in this group receive sham acupuncture treatment at first. afterwards crossover study is scheduled to be performed
arm group label: Euglycon
arm group type: Experimental
description: Glibenclamide (Euglucon, Roche Pharma) is administered 3 hours before FMD measurement.
arm group label: Celebrex
arm group type: Experimental
description: Celebrex(celecoxib, pfizer) 200mg twice daily is administered for 5 days before FMD measurement.
intervention type: Device
intervention name: Active acupuncture
description: 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
arm group label: Celebrex
arm group label: Euglycon
arm group label: active acupuncture
intervention type: Device
intervention name: Sham acupuncture
description: 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.
arm group label: Sham acupuncture
intervention type: Drug
intervention name: Euglucon 5mg
description: 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.
arm group label: Euglycon
arm group label: active acupuncture
other name: Glibenclamide
intervention type: Drug
intervention name: Celebrex 200mg
description: 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
arm group label: Celebrex
arm group label: active acupuncture
other name: Celecoxib
criteria: 
gender: All
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Weon Kim
role: Principal Investigator
affiliation: Kyunghee University Medical Center
last name: Weon Kim, Professor
phone: 82-2-958-8176
email: mylovekw@hanmail.net
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyunghee University Medical Center
investigator full name: Weon Kim
investigator title: Professor
mesh term: Reperfusion Injury
mesh term: Ischemia
mesh term: Glyburide
mesh term: Celecoxib