Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers (IROX-NH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natalie Løvland Halladin, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01486212
First received: November 17, 2011
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition
Ischemia-reperfusion Injury

Study Type: Observational
Official Title: Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Malondialdehyde (MDA) in muscle. [ Time Frame: A change from baseline to 30 minutes after ischemia. ] [ Designated as safety issue: No ]
    Malondialdehyde (MDA), is a direct product of the lipidperoxidation occuring during reperfusion. It is caused by damage done by the free radicals.


Secondary Outcome Measures:
  • Malondialdehyde (MDA) in blood [ Time Frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion. ] [ Designated as safety issue: No ]
  • Vitamin C [ Time Frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Interleukin (IL)- 1β, IL-6 og TNF-α are pro-inflammatory markers. IL-4 og IL-10 are anti-inflammatory markers.


Enrollment: 10
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy volunteers.
Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
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.

Criteria

Inclusion Criteria:

  • Male
  • Between 18 and 40 years.
  • Non smokers.
  • No known history of familiar cardio/vascular diseases.
  • No intake of prescription medicine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486212

Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Natalie Halladin, MD Herlev Hospital
  More Information

No publications provided

Responsible Party: Natalie Løvland Halladin, M.D., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01486212     History of Changes
Other Study ID Numbers: IROX-NH
Study First Received: November 17, 2011
Last Updated: December 11, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Herlev Hospital:
Ischemia-reperfusion injury
Oxidative markers
Inflammatory markers

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on August 28, 2014