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

NCT01486212 | Completed

• 1 other identifier: IROX-NH
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia-reperfusion Injury

Keywords

Ischemia-reperfusion injury; Oxidative markers; Inflammatory markers

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Malondialdehyde (MDA) in blood

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

• Vitamin C

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

• YKL-40

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

• Cytokines (Interleukin 1β,4,6,10 og TNF-α)

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

Study Arms (1)

Healthy volunteers.

Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalie Halladin, MD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

DK (1)