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The effects of cholesterol-lowering medication on skeletal muscle functioning

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22168
Enrollment
30
Registered
2015-10-20
Start date
2015-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Statin associated muscle symptoms muscle functioning (contraction efficiency, muscle relaxation, muscle fatigue) whole body aerobic fitness mitochondrial function

Interventions

All study participants will undergo a medical screening session of 1 hour to determine whether they comply with the in- and exclusion criteria. The medical screening will contain an elaborate physical

Sponsors

Radboud University Nijmegen Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o Age: 18-70 years old o Current statin user (group 1-2) for at least 3 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 participation o Impaired liver function (ALAT, ASAT, gamma-GT > 3x ULN) o Known hereditary muscle defect, creatine kinase >5 x ULN o known mitochondrial disease o Medication known to potentially interfere with muscle metabolism (fibrates, Beta blockers, laxatives, diuretics, bronchodilatators) o Impaired kidney function (creatinine 100 µmol/l) o Diabetes mellitus o Engagement in exercise for more than two hours per week

Design outcomes

Secondary

MeasureTime frame
o Mitochondrial number (in muscle biopsy) o Blood parameters: lipid profile (total cholesterol, HDL-, LDL-cholesterol, triglycerides), liver enzymes (ASAT, ALAT, gamma-GT), creatine kinase, pyruvate and lactate o Statin concentrations in the muscle and blood o Questionnaires on muscle complaints (Short-form McGill pain questionnaire and Short-form Brief Pain Inventory)

Primary

MeasureTime frame
oEnergy generating capacity of muscle mitochondria (in muscle biopsy) oMuscle function (= muscle force, contractile speed, relaxation and fatigability) oCardiorespiratory fitness (incremental cycling test)

Contacts

Public ContactSilvie Timmers

Radboud University Nijmegen Medical Centre - Department of Physiology

Silvie.timmers@radboudumc.nl+31 24 361 42 22

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)