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

This study has been completed.
Sponsor:
Collaborator:
The Dunhill Medical Trust
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01047163
First received: January 11, 2010
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
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
Myopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Maintenance of Muscle Mass in Older People: the Negative Impact of Statin Therapy

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Increase in MAFbx (atrophy gene) mRNA expression in those on Statin therapy [ Time Frame: On study visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

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

Enrollment: 18
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Statin
Men aged 65-75yr on Simvastatin therapy presenting with muscle soreness
Control
Men, aged 65-75yr not on Statin therapy

  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01047163

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

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01047163     History of Changes
Other Study ID Numbers: RB03DR 
Study First Received: January 11, 2010
Last Updated: April 26, 2016
Health Authority: United Kingdom: Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Nottingham:
Muscle soreness
Simvastatin
Men
Muscle Atrophy

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

ClinicalTrials.gov processed this record on August 28, 2016