Ischemia Reperfusion: Prostaglandins and Antioxidants

May 10, 2017 updated by: Mark Rakobowchuk, University of Essex

The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Essex
      • Colchester, Essex, United Kingdom, CO4 3SQ
        • University of Essex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 15 minutes after ischemia-reperfusion injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at 15 minutes after ischemia-reperfusion injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Essex

Investigators

  • Principal Investigator: Mark Rakobowchuk, PhD, Thompson Rivers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (ESTIMATE)

August 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAPC
  • DBD0300 (OTHER: Biological Sciences)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Reperfusion Injury

Clinical Trials on Antioxidant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe