The Role of Allopurinol in Improving Muscle Energetics in Sarcopenia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by University of Dundee
Sponsor:
Information provided by (Responsible Party):
Dr. Jacob George, University of Dundee
ClinicalTrials.gov Identifier:
NCT01550107
First received: March 7, 2012
Last updated: March 9, 2012
Last verified: March 2012

March 7, 2012
March 9, 2012
October 2012
September 2014   (final data collection date for primary outcome measure)
Improvement in Muscle energetics as measured by MR-spectroscopy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
PCr repletion,Post-exercise muscle perfusion via arterial spin labelling (ASL) Pi/PCr ratio (a measure of ADP levels) Change in muscle volume (as measured by cross-sectional area on MR obtained during perfusion mapping) Short Performance Battery test
Same as current
Complete list of historical versions of study NCT01550107 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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The Role of Allopurinol in Improving Muscle Energetics in Sarcopenia
A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Primary Sarcopenia

Sarcopenia is defined as the presence of low muscle mass and either decreased muscle strength or function. It is increasingly becoming a significant cause of frailty, loss of independence and physical disability in ageing western populations. Recent experimental evidence has revealed that skeletal muscle is particularly susceptible to damaging molecules that result in oxidative stress and that oxidative stress plays a prominent role in the development and progression of sarcopenia. The investigators have previously shown that the xanthine oxidase inhibitor allopurinol is able to abolish vascular oxidative stress and improve endothelial function in cohorts such as optimally treated chronic heart failure and chronic kidney disease. Recently, the investigators have also shown that allopurinol improves exercise tolerance and time to ST-depression in optimally treated coronary artery disease, suggesting that allopurinol could also exert its effects through ATP and/or oxygen sparing mechanisms.

Therefore, we propose a randomised double blind placebo-controlled parallel group trial of allopurinol in patients with primary sarcopenia using MR-spectroscopy and Flow Mediated Dilatation to investigate the possible mechanisms that underlie this exciting possibility

this section will be completed once the study is officially recruiting

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sarcopenia
  • Drug: Allopurinol
    300mg b.d for 24 weeks
  • Drug: Lactose tablets
    matched placebo tablets b.d
  • Active Comparator: Allopurinol
    Intervention: Drug: Allopurinol
  • Placebo Comparator: Lactose tablets
    Intervention: Drug: Lactose tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 65 and over
  • Muscle strength (grip strength<20kg women;<30kg men) AND physical performance (Short Physical Performance Battery test score less than or equal to 8/12)2 This will ensure both that the study population have sarcopenia according to European consensus guidelines
  • Gait speed less than 0.8m/s

Exclusion Criteria:

  • Previously enrolled into the study
  • Pre-existing diagnosis of heart failure or any malignancy (excluding basal cell carcinoma)
  • Documented intolerance to Allopurinol
  • Immobility that would render the patient incapable of doing the Short performance Battery Test (SPBT)
Both
40 Years and older
No
Contact: Jacob George, MRCP MD +44 1382 660111 ext 33450 j.george@dundee.ac.uk
United Kingdom
 
NCT01550107
GEO006
No
Dr. Jacob George, University of Dundee
University of Dundee
Not Provided
Principal Investigator: Jacob George, MRCP MD University of Dundee
Study Director: Allan Struthers, MD FRCP University of Dundee
Study Director: Marion McMurdo, MD FRCP University of Dundee
Study Director: Miles Witham, PhD FRCP University of Dundee
Study Director: Graeme Houston, FRCP FRCR University of Dundee
Study Director: Steve Gandy, PhD University of Dundee
Study Director: Peter Donnan, PhD FRSS University of Dundee
University of Dundee
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP