The effects of statins on skeletal muscle mitochondria:a pilot study?

Completed

• Conditions: skeletspier mitochondriale functie, algemene spierfunctie en fitheid; the effects of statins on musle mitochondrial function; the effects of statins on the aerobic energy metabolism; 10028302

• Registration Number: NL-OMON42199
• Lead Sponsor: Integrative fysiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-03-25
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

o Age: 18-70 years old
o Current statin user: (group 1-2) for at least three months
o Mentally able/ allowed to give informed consent

Exclusion Criteria

o familial hypercholesterolemia
o history of a cardiovascular event within 1 year of study participatie
o impaired liver function ( ALAT, ASAT, gamma-GT > 3x ULN)
o known hereditary muscle defect; creatine kinase > 5x ULN
known mitochondrial disorder
o Medication known to potentially interfere with muscle metabolism (fibrates,
Beta blockers, laxatives, diuretics, bronchodilatators)
o Impaired kidney function: creatinin <50 or >100 umol/l
o Diabetes mellitus
o Engagement in exercise for more than two hours per week
o contraindications for the exercise test (as explained in the protocol and the SOP) or muscle biopsy (see SOP)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome paramters are:<br /><br><br /><br>1.the energy generating capacity of muscle mitochondria,<br /><br>2. muscle function (muscle strength, muscle contraction efficiency,muscle<br /><br>fatigability),<br /><br>3. maximal aerobic capacity<br /><br><br /><br>These parameters shall be compared between the three study groups</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Mitochondrial number (in muscle biopsy),<br /><br>2. Blood paramters: Lipid profile (Total cholesterol, HDL-, LDL-cholesterol,<br /><br>triglycerides), liver enzymes (ASAT, ALAT, gamma-GT), creatine kinase,<br /><br>pyruvate, lactate<br /><br>3. statin concentrations in muscle and blood<br /><br>4. Questionnaires on muscle complaints (Short-form McGill pain questionnaire<br /><br>and Short-form Brief Pain Inventory)</p><br>