Allopurinol in Functional Impairment (ALFIE) Trial: 'Improving Muscle Strength'

NCT01550107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-03-20

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01550107 on ClinicalTrials.gov