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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
Sponsor:
Information provided by (Responsible Party):
Natalie Løvland Halladin, Herlev Hospital

November 17, 2011
December 6, 2011
December 12, 2012
November 2011
December 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01486212 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
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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Observational
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Probability Sample
Healthy volunteers. Male aged 18-40 years. Non smokers. No known history of familiar cardio/vascular diseases. No intake of prescription medicine.
Ischemia-reperfusion Injury
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Healthy volunteers.
Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Same as current
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • Between 18 and 40 years.
  • Non smokers.
  • No known history of familiar cardio/vascular diseases.
  • No intake of prescription medicine.
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01486212
IROX-NH
No
Not Provided
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Natalie Løvland Halladin, Herlev Hospital
Herlev Hospital
Not Provided
Principal Investigator: Natalie Halladin, MD Herlev Hospital
Herlev Hospital
December 2012