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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT00285181
First received: January 31, 2006
Last updated: August 8, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention
Healthy
Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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:
  • Blood lipids before treatment and after treatment
  • LDL composition before and after treatment

Estimated Enrollment: 24
Study Start Date: November 2005
Study Completion Date: April 2007
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 18.0 and 25.00

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00285181

Locations
France
Centre d'Investigation Clinique
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Pierre PETIT, MD-PhD Centre d'Investigation Clinique
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00285181     History of Changes
Other Study ID Numbers: UF7808
Study First Received: January 31, 2006
Last Updated: August 8, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
persons

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 20, 2014