Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers

Completed

• Conditions: Ischemia-reperfusion Injury

• Registration Number: NCT01486212
• Lead Sponsor: Herlev Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-17
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark