Ischemia Reperfusion: Prostaglandins and Antioxidants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Essex.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Essex
Information provided by (Responsible Party):
Mark Rakobowchuk, University of Essex
ClinicalTrials.gov Identifier:
NCT01666587
First received: August 9, 2012
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?
| Condition | Intervention |
|---|---|
|
Ischemic Reperfusion Injury |
Dietary Supplement: Antioxidant Drug: Prostaglandin inhibitor (Ibuprophen) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans |
Resource links provided by NLM:
Further study details as provided by University of Essex:
Primary Outcome Measures:
- Change in flow mediated dilation [ Time Frame: Change from baseline at 15 minutes after ischemia-reperfusion injury ] [ Designated as safety issue: No ]Flow mediated dilation is a measure of vascular function and is measured as the outcome before and after an injury to the inner lining of the artery.
Secondary Outcome Measures:
- Change in low flow mediated constriction [ Time Frame: Change from baseline at 15 minutes after ischemia-reperfusion injury ] [ Designated as safety issue: No ]low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control
Control trial to determine the impact of the ischemic injury on vascular function without intervention
|
|
|
Experimental: Antioxidant load
Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery
|
Dietary Supplement: Antioxidant |
|
Experimental: Prostaglandin inhibition
Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery
|
Drug: Prostaglandin inhibitor (Ibuprophen)
Other Name: ibuprofen
|
|
Experimental: Combined
Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery
|
Dietary Supplement: Antioxidant
Drug: Prostaglandin inhibitor (Ibuprophen)
Other Name: ibuprofen
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy males
- Healthy females
Exclusion Criteria:
- Smokers
- Cardiovascular disease
- Peripheral vascular disease
- Neurological deficits
- Diabetes Type I or II
- Pregnant women
- Adverse reactions to Ibuprofen
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666587
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666587
Locations
| United Kingdom | |
| University of Essex | Recruiting |
| Colchester, Essex, United Kingdom, CO4 3SQ | |
| Contact: Mark Rakobowchuk, PhD 44(0)1206873332 merako@essex.ac.uk | |
| Principal Investigator: Mark Rakobowchuk, PhD | |
Sponsors and Collaborators
University of Essex
Investigators
| Principal Investigator: | Mark Rakobowchuk, PhD | University of Essex |
More Information
No publications provided
| Responsible Party: | Mark Rakobowchuk, Principle Investigator, University of Essex |
| ClinicalTrials.gov Identifier: | NCT01666587 History of Changes |
| Other Study ID Numbers: | IRAPC, DBD0300 |
| Study First Received: | August 9, 2012 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Antioxidants Reperfusion Injury Cardiovascular Diseases Pathologic Processes Postoperative Complications Vascular Diseases Prostaglandin Antagonists |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents |
ClinicalTrials.gov processed this record on February 27, 2015