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Completed

NCT Number: NCT01550107

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Dundee Medical School

Dundee, Angus, DD1 9SY, United Kingdom

About this study

this section will be completed once the study is officially recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 65 and over 6-Minute Walk Distance <400m

Exclusion criteria

Documented history of peripheral arterial disease. Pre-existing diagnosis of severe heart failure (LVEF<35%). Malignancy under active treatment (excluding basal cell carcinoma). Severe COPD (Physician diagnosis). Intolerance to allopurinol. Individuals with Active Acute Gout currently taking allopurinol; or those who have stopped taking allopurinol ≤1month previously for this condition.

On long term high dose steroids (eq. Prednisolone>10mg/day due to risk of steroid induced myopathy and osteoporosis).

Immobility that would render the patient incapable of doing the Short Physical Performance Battery Test (SPPB) or 6MWT.

Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded.

Cognitive impairment precluding informed consent. Any other considered by a study physician to be inappropriate for inclusion.

Treatment and study plan

Allopurinol

Drug

300mg b.d for 24 weeks

Lactose tablets

Drug

matched placebo tablets b.d

Primary outcomes

  1. Improvement in Muscle energetics as measured by MR-spectroscopy

    Time frame: 24 weeks

    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)

Secondary outcomes

  1. Short Performance Battery test

    Time frame: 24 weeks

  2. 6-Minute Walk Test

    Time frame: 24 weeks

  3. Change in Flow Mediated Dilatation

    Time frame: 24 weeks

  4. Markers of oxidative stress (F2-Isoprostanes)

    Time frame: 24 weeks

  5. Quality of Life measured by EuroQOL EQ5D questionnaire

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Primary Sarcopenia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2012
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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