Back to resultsEffects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring persons
Eligibility Criteria
Inclusion Criteria: BMI between 18.0 and 25.00 Exclusion Criteria: -
Sites / Locations
- Centre d'Investigation Clinique
Outcomes
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
Full Information
NCT ID
NCT00285181
First Posted
January 31, 2006
Last Updated
August 8, 2007
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT00285181
Brief Title
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.
Official Title
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
persons
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Primary Outcome Measure Information:
Title
Blood antioxidant status before treatment and after treatment.
Title
Lipid and protein peroxidation indexes before treatment and after treatment.
Title
In vitro mitochondrial respiration, enzymatic activities and calcium release parameters before treatment and after treatment.
Secondary Outcome Measure Information:
Title
Blood lipids before treatment and after treatment
Title
LDL composition before and after treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI between 18.0 and 25.00
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre PETIT, MD-PhD
Organizational Affiliation
Centre d'Investigation Clinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigation Clinique
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
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Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.
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