The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels

NCT ID: NCT00534924

Last Updated: 2007-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31

Brief Summary

Ischemic injury to muscular tissue is common in cardiovascular medicine. The most effective treatment to avoid ischemic damage is the rapid re-establishment of reperfusion. However, reperfusion itself can result in additional damage to ischemic tissue. This phenomenon is called ischemia - reperfusion (IR) injury and is caused by different pathologic mechanisms.

Therapies are required which can be administered after the onset of an ischemic event to protect the tissue against IR injury. Therefore, a promising strategy to reduce IR injury is post-conditioning.

Likewise, pharmacological therapies administered after the onset of reperfusion might prevent tissue injury. We have recently shown that high concentrations of exogenous vitamin C abrogate experimental IR injury of the forearm vasculature in patients with peripheral artery disease and in healthy subjects.

Study hypothesis

We hypothesize that the administration of mechanical post-conditioning or of high-dose vitamin C may protect skeletal muscle against IR injury. This shall be studied employing MR spectroscopy of the leg, which is an established model to assess muscle aerobic energy metabolism.

Design

Three periods, three way cross over study in 10 volunteers. One screening visit, three one-day study days with two washout periods of >3 days in between are scheduled for each participant. The order of experimental days will be randomized. After the last treatment a final follow-up examination will be performed within one week.

Conditions

Ischemia Reperfusion Injury

Keywords

IR injury; MRI; Vitamin C; Postconditioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

No intervention after IR injury

Group Type: PLACEBO_COMPARATOR

no intervention

Intervention Type: OTHER

2

Postconditioning

Group Type: EXPERIMENTAL

Postconditioning

Intervention Type: PROCEDURE

3

Vit. C

Group Type: EXPERIMENTAL

Vit C

Intervention Type: DRUG

Interventions

Vit C

Intervention Type: DRUG

Postconditioning

Intervention Type: PROCEDURE

no intervention

Intervention Type: OTHER

Eligibility Criteria

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

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 preceding 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 metallic or paramagnetic device not removable
• Claustrophobia
• Regular use of supplementary oral Vitamin C or Vitamin C containing substances

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Principal Investigators

Michael Wolzt, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Head of research group

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Martin Andreas, MD

Role: CONTACT

Phone: 0043404002983

Email: martin.andreas@meduniwien.ac.at

Facility Contacts

Martin Andreas, MD

Role: primary

Other Identifiers

EudraCT: 2007-002520-16

Identifier Type: -

Identifier Source: org_study_id