skeletspier mitochondriale functie, algemene spierfunctie en fitheid the effects of statins on musle mitochondrial function the effects of statins on the aerobic energy metabolism
Conditions
Interventions
symptomatic + asymptomatic statin users
placebo intake for a period of 12 weeks in a singleblind fashion
mitochondrial energy metabolism
skeletal muscle
Sponsors
Integrative fysiologie
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study outcome paramters are: 1.the energy generating capacity of muscle mitochondria, 2. muscle function (muscle strength, muscle contraction efficiency,muscle fatigability), 3. maximal aerobic capacity These parameters shall be compared between the three study groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mitochondrial number (in muscle biopsy), 2. Blood paramters: Lipid profile (Total cholesterol, HDL-, LDL-cholesterol, triglycerides), liver enzymes (ASAT, ALAT, gamma-GT), creatine kinase, pyruvate, lactate 3. statin concentrations in muscle and blood 4. Questionnaires on muscle complaints (Short-form McGill pain questionnaire and Short-form Brief Pain Inventory) | — |
Countries
The Netherlands
Outcome results
None listed