Back to results

Ischemia Reperfusion: Prostaglandins and Antioxidants

Primary Purpose

Ischemic Reperfusion Injury

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Antioxidant

Prostaglandin inhibitor (Ibuprophen)

About this trial

This is an interventional basic science trial for Ischemic Reperfusion Injury

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Essex

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

control

Antioxidant load

Prostaglandin inhibition

Combined

Arm Description

Control trial to determine the impact of the ischemic injury on vascular function without intervention

Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery

Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery

Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery

Outcomes

Primary Outcome Measures

Change in flow mediated dilation

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

low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury

Full Information

NCT ID

NCT01666587

First Posted

August 9, 2012

Last Updated

May 10, 2017

Sponsor

University of Essex

1. Study Identification

Unique Protocol Identification Number

NCT01666587

Brief Title

Ischemia Reperfusion: Prostaglandins and Antioxidants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Essex

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Reperfusion Injury

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

Control trial to determine the impact of the ischemic injury on vascular function without intervention

Arm Title

Antioxidant load

Arm Type

Experimental

Arm Description

Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery

Arm Title

Prostaglandin inhibition

Arm Type

Experimental

Arm Description

Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery

Arm Title

Combined

Arm Type

Experimental

Arm Description

Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery

Intervention Type

Dietary Supplement

Intervention Name(s)

Antioxidant

Intervention Type

Drug

Intervention Name(s)

Prostaglandin inhibitor (Ibuprophen)

Other Intervention Name(s)

ibuprofen

Primary Outcome Measure Information:

Title

Change in flow mediated dilation

Description

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.

Time Frame

Change from baseline at 15 minutes after ischemia-reperfusion injury

Secondary Outcome Measure Information:

Title

Change in low flow mediated constriction

Description

low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury

Time Frame

Change from baseline at 15 minutes after ischemia-reperfusion injury

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Rakobowchuk, PhD

Organizational Affiliation

Thompson Rivers University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Essex

City

Colchester

State/Province

Essex

ZIP/Postal Code

CO4 3SQ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Ischemia Reperfusion: Prostaglandins and Antioxidants

We'll reach out to this number within 24 hrs