Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT00285181
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-01
• Study Completion: 2007-04
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-08
• Last Update Posted: 2007-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• BMI between 18.0 and 25.00

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Blood lipids before treatment and after treatment
LDL composition before and after treatment

Trial Locations

Locations (1)

Centre d'Investigation Clinique; 🇫🇷 Montpellier, France