Maintenance of Muscle Mass in Older People: the Negative Impact of Statin Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047163
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : April 27, 2016
The Dunhill Medical Trust
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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.

Condition or disease

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Maintenance of Muscle Mass in Older People: the Negative Impact of Statin Therapy
Study Start Date : June 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Men aged 65-75yr on Simvastatin therapy presenting with muscle soreness
Men, aged 65-75yr not on Statin therapy

Primary Outcome Measures :
  1. Increase in MAFbx (atrophy gene) mRNA expression in those on Statin therapy [ Time Frame: On study visit ]

Secondary Outcome Measures :
  1. Expression of genes that regulate muscle protein balance. [ Time Frame: Before, 2 hours after aminoacid tracer infusion and 2 hours after a 40 mU/m2 hyperinsulinaemic, euglycaemic clamp with aminoacid infusion (10g/h) ]

Biospecimen Retention:   Samples With DNA
Plasma, Muscle biopsy, Serum & Whole blood

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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community Sample

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047163

United Kingdom
David Greenfield Physiology Laboratories
Nottingham, Nottinghamshire, United Kingdom, NG72UH
Sponsors and Collaborators
University of Nottingham
The Dunhill Medical Trust
Principal Investigator: Paul L Greenhaff, PhD University of Nottingham

Publications of Results:
Other Publications:
Responsible Party: University of Nottingham Identifier: NCT01047163     History of Changes
Other Study ID Numbers: RB03DR
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Nottingham:
Muscle soreness
Muscle Atrophy

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents