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

Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00285181

Enrollment

Registered

2006-02-01

Start date

2005-11-30

Completion date

2007-04-30

Last updated

2007-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

persons

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

Interventions

DRUGSimvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI between 18.0 and 25.00

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Blood lipids before treatment and after treatment	—
LDL composition before and after treatment	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026