Allopurinol in Functional Impairment (ALFIE) Trial: 'Improving Muscle Strength'
NCT01550107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2018-03-20
Summary
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
Conditions
Interventions
- DRUG
-
Allopurinol
300mg b.d for 24 weeks
- DRUG
-
Lactose tablets
matched placebo tablets b.d
Sponsors & Collaborators
-
University of Dundee
lead OTHER
Principal Investigators
-
Jacob George, MRCP MD · University of Dundee
-
Allan Struthers, MD FRCP · University of Dundee
-
Marion McMurdo, MD FRCP · University of Dundee
-
Miles Witham, PhD FRCP · University of Dundee
-
Graeme Houston, FRCP FRCR · University of Dundee
-
Steve Gandy, PhD · University of Dundee
-
Peter Donnan, PhD FRSS · University of Dundee
-
Clare Clarke, PhD MCSP · University of Dundee
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-01
- Primary Completion
- 2017-08-01
- Completion
- 2017-09-20
Countries
- United Kingdom
Study Locations
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