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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01550107
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
Dr. Jacob George, University of Dundee

Brief 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

Condition or disease Intervention/treatment Phase
Sarcopenia Drug: Allopurinol Drug: Lactose tablets Phase 4

Detailed Description:
this section will be completed once the study is officially recruiting

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Primary Sarcopenia
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Allopurinol
Allopurinol 600mg tablets
Drug: Allopurinol
300mg b.d for 24 weeks

Placebo Comparator: Lactose tablets
Placebo Lactose tablets
Drug: Lactose tablets
matched placebo tablets b.d

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01550107

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United Kingdom
University of Dundee Medical School
Dundee, Angus, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
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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
Principal Investigator: Clare Clarke, PhD MCSP University of Dundee
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Responsible Party: Dr. Jacob George, Chief Investigator, University of Dundee Identifier: NCT01550107    
Other Study ID Numbers: GEO006
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Keywords provided by Dr. Jacob George, University of Dundee:
Xanthine Oxidase
MR Spectroscopy
Additional relevant MeSH terms:
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Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs