Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers (IROX-NH)
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|ClinicalTrials.gov Identifier: NCT01486212|
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : December 12, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine.
- Malondialdehyde (MDA) in muscle. [ Time Frame: 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.
- Malondialdehyde (MDA) in blood [ Time Frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion. ]
- Vitamin C [ Time Frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion. ]Vitamin C is an antioxidant.
- YKL-40 [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486212
|Herlev, Denmark, 2730|
|Principal Investigator:||Natalie Halladin, MD||Herlev Hospital|