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Ischemia Reperfusion: Prostaglandins and Antioxidants

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ClinicalTrials.gov Identifier: NCT01666587
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Mark Rakobowchuk, University of Essex

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ischemic Reperfusion Injury Dietary Supplement: Antioxidant Drug: Prostaglandin inhibitor (Ibuprophen) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans
Study Start Date : August 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
Drug Information available for: Ibuprofen

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in flow mediated dilation [ Time Frame: Change from baseline at 15 minutes after ischemia-reperfusion injury ]
    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 :
  1. Change in low flow mediated constriction [ Time Frame: Change from baseline at 15 minutes after ischemia-reperfusion injury ]
    low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666587


Locations
United Kingdom
University of Essex
Colchester, Essex, United Kingdom, CO4 3SQ
Sponsors and Collaborators
University of Essex
Investigators
Principal Investigator: Mark Rakobowchuk, PhD Thompson Rivers University
More Information
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Responsible Party: Mark Rakobowchuk, Principle Investigator, University of Essex
ClinicalTrials.gov Identifier: NCT01666587     History of Changes
Other Study ID Numbers: IRAPC
DBD0300 ( Other Identifier: Biological Sciences )
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Antioxidants
 Prostaglandin Antagonists
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists