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

University Hospital, Montpellier24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

SimvastatinDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI between 18.0 and 25.00 Exclusion Criteria: \-

Locations (1)

Centre d'Investigation Clinique

Montpellier, France

Outcomes

Primary Outcomes

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 Outcomes

Blood lipids before treatment and after treatment

LDL composition before and after treatment

Data from ClinicalTrials.gov

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