Clinical trial · Observational
Maintenance of Muscle Mass in Older People: the Negative Impact of Statin Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A major contributor to frailty and immobility in the elderly is the age related loss of muscle mass (sarcopenia). Cardiovascular disease (CVD) is the leading cause of mortality in the elderly, with high blood cholesterol and lipids being the major modifiable risk factor. Statins reduce blood cholesterol, but muscle related pain, tenderness and discomfort (myopathy) is an adverse event associated with statin therapy, with older people being at a much greater risk. Statin myopathy presents as muscle aches and weakness, with or without evidence of muscle damage; however the underlying mechanisms responsible for these symptoms are poorly understood. Using an animal model, the applicants have shown the main pathway regulating muscle protein synthesis is inhibited in statin myopathy, and genes regulating muscle protein breakdown, the inhibition of muscle carbohydrate use and inflammation are dramatically increased. Therefore we wish to determine whether these changes are seen in the muscle of older people with symptoms of statin myopathy, and whether this is associated with lower muscle mass and impaired muscle function compared with older people with no history of statin use. Identification of the mechanisms involved in statin myopathy could lead to effective therapy for older people unable to tolerate statins.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myopathy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Statin
- description
- Men aged 65-75yr on Simvastatin therapy presenting with muscle soreness
- label
- Control
- description
- Men, aged 65-75yr not on Statin therapy
Primary outcomes (1)
- measure
- Increase in MAFbx (atrophy gene) mRNA expression in those on Statin therapy
- timeFrame
- On study visit
Secondary outcomes (1)
- measure
- Expression of genes that regulate muscle protein balance.
- timeFrame
- Before, 2 hours after aminoacid tracer infusion and 2 hours after a 40 mU/m2 hyperinsulinaemic, euglycaemic clamp with aminoacid infusion (10g/h)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male * 65-75yrs * Simvastatin use with muscle soreness or no statin use * Residing in Nottinghamshire area Exclusion Criteria: * Clotting disorders or previous Cerebral Vascular Accident /Transient Ischaemic Attack /Deep Vein Thrombosis * Metabolic disease e.g. diabetes, thyroid dysfunction * Inflammatory conditions e.g. Rheumatoid Arthritis, Crohn's Disease * Tobacco smoker * Lower limb circulation problems e.g. Claudication * Epilepsy * Renal pathology * Respiratory problems including Asthma
References
Publications (4)
- BACKGROUNDNichols GA, Koro CE. Does statin therapy initiation increase the risk for myopathy? An observational study of 32,225 diabetic and nondiabetic patients. Clin Ther. 2007 Aug;29(8):1761-70. doi: 10.1016/j.clinthera.2007.08.022. PMID 17919557
- BACKGROUNDMallinson JE, Constantin-Teodosiu D, Sidaway J, Westwood FR, Greenhaff PL. Blunted Akt/FOXO signalling and activation of genes controlling atrophy and fuel use in statin myopathy. J Physiol. 2009 Jan 15;587(1):219-30. doi: 10.1113/jphysiol.2008.164699. Epub 2008 Nov 10. PMID 19001041
- BACKGROUNDHanai J, Cao P, Tanksale P, Imamura S, Koshimizu E, Zhao J, Kishi S, Yamashita M, Phillips PS, Sukhatme VP, Lecker SH. The muscle-specific ubiquitin ligase atrogin-1/MAFbx mediates statin-induced muscle toxicity. J Clin Invest. 2007 Dec;117(12):3940-51. doi: 10.1172/JCI32741. PMID 17992259
- RESULTMallinson JE, Marimuthu K, Murton A, Selby A, Smith K, Constantin-Teodosiu D, Rennie MJ, Greenhaff PL. Statin myalgia is not associated with reduced muscle strength, mass or protein turnover in older male volunteers, but is allied with a slowing of time to peak power output, insulin resistance and differential muscle mRNA expression. J Physiol. 2015 Mar 1;593(5):1239-57. doi: 10.1113/jphysiol.2014.285577. Epub 2015 Jan 26. PMID 25620655