The Role of Allopurinol in Improving Muscle Energetics in Sarcopenia
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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 |
- 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 |
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| Contact: Jacob George, MRCP MD | +44 1382 660111 ext 33450 | j.george@dundee.ac.uk |
| 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 | |
| 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 Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013