Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.
To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and antioxidant status at rest and after exercise, on mitochondrial respiration and calcium release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.|
- Blood antioxidant status before treatment and after treatment.
- Lipid and protein peroxidation indexes before treatment and after treatment.
- In vitro mitochondrial respiration, enzymatic activities and calcium release parameters before treatment and after treatment.
- Blood lipids before treatment and after treatment
- LDL composition before and after treatment
|Study Start Date:||November 2005|
|Study Completion Date:||April 2007|
Day 1 : baseline oxidative status, lipid profile, exercice test, start of randomized treatment Day 53 : muscular biopsy Day 57 : follow-up oxidative status, lipid profile, exercice test, end of treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285181
|Centre d'Investigation Clinique|
|Montpellier, France, 34295|
|Principal Investigator:||Pierre PETIT, MD-PhD||Centre d'Investigation Clinique|