The effects of post-conditioning and administration of Vitamin C on intramuscular high energy phosphate levels

Conditions: ischemia reperfusion injury
MedDRA version: 9.1Level: LLTClassification code 10023034Term: Ischemia peripheral

Registration Number: EUCTR2007-002520-16-AT

Lead Sponsor: niversitätsklinik für klinische Pharmakologie, Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

-Men aged between 18 and 45 years
-Nonsmoker for more than 3 months
-Body mass index between 18 and 25 kg/m2
-Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any of the following will exclude a subject from the study:
-Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preciding the study
-Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
-Treatment in the previous 3 weeks with any drug including over-the-counter drugs.
-Symptoms of a clinically relevant illness in the 2 weeks before the first study day
-History or presence of gastrointestinal, liver of kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug
-Blood donation during the previous 3 weeks
-History of hypersensitivity to parenteral vitamin C.
-Glucose-6-phosphate dehydrogenase deficiency
-Thalassemia, haemochromatosis
-History of urolithiasis
-Any magnetic or paramagnetic device not removable
-Claustrophobia
-Regular use of supplementary oral Vitamin C or Vitamin C containing substances

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether mechanical post-conditioning prevents skeletal muscle IR injury.<br>To study whether high concentrations of exogenous vitamin C prevent skeletal muscle IR injury.<br>;Secondary Objective: To provide data about the time course of high energy phosphate levels (ATP, phosphocreatine and inorganci phosphate) and pH in skeletal muscle tissue after the onset of ischemia and reperfusion.<br>To determine systemic plasma concentrations of vitamin C and of markers of oxidative stress before and after 20 minutes of leg ischemia in the absence and presence of post-conditioning or vitamin C administration<br>To determine the concentration of cellular proteins like NF-?B before and after the onset of ischemia<br>;Primary end point(s): -Change in cellular high energy phosphate levels and venous pH concentration<br>

Secondary Outcome Measures