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Completed

NCT Number: NCT01486212

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Malondialdehyde (MDA) in blood

    Time frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Acronym: IROX-NH

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2011
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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