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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemia-reperfusion Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Between 18 and 40 years. Non smokers. No known history of familiar cardio/vascular diseases. No intake of prescription medicine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers.<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia-reperfusion injury, Oxidative markers, Inflammatory markers