Back to resultsIschemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers (IROX-NH)
Primary Purpose
Ischemia-reperfusion Injury
Status
Completed
Phase
Locations
Denmark
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Ischemia-reperfusion Injury focused on measuring Ischemia-reperfusion injury, Oxidative markers, Inflammatory markers
Eligibility Criteria
Inclusion Criteria:
- Male
- Between 18 and 40 years.
- Non smokers.
- No known history of familiar cardio/vascular diseases.
- No intake of prescription medicine.
Sites / Locations
- Herlev Hospital
Arms of the Study
Arm 1
Arm Type
Arm Label
Healthy volunteers.
Arm Description
Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Malondialdehyde (MDA) in blood
Vitamin C
Vitamin C is an antioxidant.
YKL-40
YKL-40 is a marker that become elevated if local inflammation occurs.
Cytokines (Interleukin 1β,4,6,10 og TNF-α)
Interleukin (IL)- 1β, IL-6 og TNF-α are pro-inflammatory markers. IL-4 og IL-10 are anti-inflammatory markers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01486212
Brief Title
Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
Acronym
IROX-NH
Official Title
Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
Study Type
Observational
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia-reperfusion Injury
Keywords
Ischemia-reperfusion injury, Oxidative markers, Inflammatory markers
7. Study Design
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers.
Arm Description
Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine.
Primary Outcome Measure Information:
Title
Malondialdehyde (MDA) in muscle.
Description
Malondialdehyde (MDA), is a direct product of the lipidperoxidation occuring during reperfusion. It is caused by damage done by the free radicals.
Time Frame
A change from baseline to 30 minutes after ischemia.
Secondary Outcome Measure Information:
Title
Malondialdehyde (MDA) in blood
Time Frame
A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Title
Vitamin C
Description
Vitamin C is an antioxidant.
Time Frame
A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Title
YKL-40
Description
YKL-40 is a marker that become elevated if local inflammation occurs.
Time Frame
A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Title
Cytokines (Interleukin 1β,4,6,10 og TNF-α)
Description
Interleukin (IL)- 1β, IL-6 og TNF-α are pro-inflammatory markers. IL-4 og IL-10 are anti-inflammatory markers.
Time Frame
A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
Between 18 and 40 years.
Non smokers.
No known history of familiar cardio/vascular diseases.
No intake of prescription medicine.
Study Population Description
Healthy volunteers. Male aged 18-40 years. Non smokers. No known history of familiar cardio/vascular diseases. No intake of prescription medicine.
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Halladin, MD
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
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