Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers (IROX-NH)

Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their structure can react with other molecules resulting in cell damage. This damage is due to several mechanisms.

This is e.g what happens when human tissue is cut of from blood supply for a time, and the blood supply is again restored. The damage following the restoration of blood is known as "ischemia-reperfusion injury". The reopening of the vessels and thereby supplying oxygenated blood to the deprived tissue can in it self contribute to cell death due to excessive amounts of free radicals. Antioxidants can neutralize free radicals and thereby minimize their damage.

The purpose of the investigators methodology study is to make an ischemia-reperfusion model on healthy volunteers (on the lower limb) to examine the expression of markers that are expressed in the muscle and the blood when blood supply is cut of to an area and later restored. The investigators wish to measure the product of the damage caused by free radicals and the levels of antioxidants.

If the investigators can produce elevation of oxidative and inflammatory markers, this model can be used to test antioxidative intervention.

Study Overview

• Status: Completed
• Conditions: Ischemia-reperfusion Injury

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Healthy volunteers. Male aged 18-40 years. Non smokers. No known history of familiar cardio/vascular diseases. No intake of prescription medicine.

Description

Inclusion Criteria:

• Male
• Between 18 and 40 years.
• Non smokers.
• No known history of familiar cardio/vascular diseases.
• No intake of prescription medicine.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy volunteers.; Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malondialdehyde (MDA) in muscle.	Malondialdehyde (MDA), is a direct product of the lipidperoxidation occuring during reperfusion. It is caused by damage done by the free radicals.	A change from baseline to 30 minutes after ischemia.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malondialdehyde (MDA) in blood		A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Vitamin C	Vitamin C is an antioxidant.	A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
YKL-40	YKL-40 is a marker that become elevated if local inflammation occurs.	A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Cytokines (Interleukin 1β,4,6,10 og TNF-α)	Interleukin (IL)- 1β, IL-6 og TNF-α are pro-inflammatory markers. IL-4 og IL-10 are anti-inflammatory markers.	A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Natalie Halladin, MD, Herlev Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (ESTIMATE): December 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Inflammatory markers; Ischemia-reperfusion injury; Oxidative markers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Wounds and Injuries; Reperfusion Injury
• Other Study ID Numbers: IROX-NH