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
  Purpose

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


Condition Intervention Phase
Sarcopenia
Drug: Allopurinol
Drug: Lactose tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Primary Sarcopenia

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allopurinol Drug: Allopurinol
300mg b.d for 24 weeks
Placebo Comparator: Lactose tablets Drug: Lactose tablets
matched placebo tablets b.d

Detailed Description:

this section will be completed once the study is officially recruiting

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550107

Contacts
Contact: Jacob George, MRCP MD +44 1382 660111 ext 33450 j.george@dundee.ac.uk

Locations
United Kingdom
University of Dundee Medical School Not yet recruiting
Dundee, Angus, United Kingdom, DD1 9SY
Contact: Jacob George, MRCP MD    +44 1382 660111 ext 33450    j.george@dundee.ac.uk   
Principal Investigator: Jacob George, MRCP MD         
Sponsors and Collaborators
University of Dundee
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Jacob George, Principal Investigator, University of Dundee
ClinicalTrials.gov Identifier: NCT01550107     History of Changes
Other Study ID Numbers: GEO006
Study First Received: March 7, 2012
Last Updated: March 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:
Sarcopenia
Allopurinol
Xanthine Oxidase
MR Spectroscopy

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014