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
Sponsor:
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
  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
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 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:
Ischemia
Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Antioxidants
Prostaglandin Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014