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

Ischemia-reperfusion Injury Clinical Trial

— IROX-NH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486212
• Other study ID #: IROX-NH
• Status: Completed
• Phase: N/A
• First received: November 17, 2011
• Last updated: December 11, 2012
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male

• Between 18 and 40 years.

• Non smokers.

• No known history of familiar cardio/vascular diseases.

• No intake of prescription medicine.

Study Design

N/A

Related Conditions & MeSH terms

• Ischemia
• Ischemia-reperfusion Injury
• Reperfusion Injury

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Malondialdehyde (MDA) in blood		A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.	No
Secondary	Vitamin C	Vitamin C is an antioxidant.	A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.	No
Secondary	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.	No
Secondary	Cytokines (Interleukin 1ß,4,6,10 og TNF-a)	Interleukin (IL)- 1ß, IL-6 og TNF-a 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.	No