Ischemia Reperfusion: Prostaglandins and Antioxidants

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mark Rakobowchuk, University of Essex

ClinicalTrials.gov Identifier:

NCT01666587

First received: August 9, 2012

Last updated: May 10, 2017

Last verified: May 2017

History of Changes

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: Participant 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:

MedlinePlus related topics: Antioxidants

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysine

U.S. FDA Resources

Further study details as provided by Mark Rakobowchuk, University of Essex:

Primary Outcome Measures:

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:

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


Enrollment:	12
Study Start Date:	August 2012
Study Completion Date:	August 2013
Primary Completion Date:	April 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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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


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 )
Study First Received:	August 9, 2012
Last Updated:	May 10, 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

ClinicalTrials.gov processed this record on July 27, 2017

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