Clinical trial NCT01486212: Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
Official title: Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia-reperfusion Injury
Keywords: Ischemia-reperfusion injury
Oxidative markers
Inflammatory markers
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Malondialdehyde (MDA) in muscle.
timeFrame: A change from baseline to 30 minutes after ischemia.
Secondary outcomes:
measure: Malondialdehyde (MDA) in blood
timeFrame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
measure: Vitamin C
timeFrame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
measure: YKL-40
timeFrame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
measure: Cytokines (Interleukin 1β,4,6,10 og TNF-α)
timeFrame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: Natalie Halladin, MD
role: PRINCIPAL_INVESTIGATOR
References: