Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury
Information source: Kyunghee University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Active acupuncture (Device); Sham acupuncture (Device); Euglucon 5mg (Drug); Celebrex 200mg (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Kyunghee University Medical Center Official(s) and/or principal investigator(s): Weon Kim, Principal Investigator, Affiliation: Kyunghee University Medical Center
Overall contact: Weon Kim, Professor, Phone: 82-2-958-8176, Email: mylovekw@hanmail.net
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.
Clinical Details
Official title: Effect of Acupuncture to Endothelial Dysfunction Induced by Ischemia-reperfusion Injury Via Adenosine Triphosphate-sensitive Potassium Channels or Prostaglandin Pathway
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: The difference of endothelial function
Secondary outcome: The difference of endothelial function
Eligibility
Minimum age: 25 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Weon Kim, Professor, Phone: 82-2-958-8176, Email: mylovekw@hanmail.net
Kyung Hee University Medical Center, Seoul 130-701, Korea, Republic of; Recruiting Weon Kim, Professor, Phone: 82-2-958-8176, Email: mylovekw@hanmail.net
Additional Information
Starting date: May 2014
Last updated: September 29, 2014
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