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OpenTrials
Completed

NCT Number: NCT00285181

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigation Clinique

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 18.0 and 25.00

Exclusion criteria

-

Treatment and study plan

simvastatin

Drug

Primary outcomes

  1. Blood antioxidant status before treatment and after treatment.

  2. Lipid and protein peroxidation indexes before treatment and after treatment.

  3. In vitro mitochondrial respiration, enzymatic activities and calcium release parameters before treatment and after treatment.

Secondary outcomes

  1. Blood lipids before treatment and after treatment

  2. LDL composition before and after treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Feb 1, 2006
Registry last updated
Aug 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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