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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550107
• Other study ID #: GEO006
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2012
• Last updated: March 19, 2018
• Start date: February 1, 2015
• Est. completion date: September 20, 2017

Study information

• Verified date: March 2018
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

this section will be completed once the study is officially recruiting

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 20, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• Allopurinol
300mg b.d for 24 weeks
• Lactose tablets
matched placebo tablets b.d

Locations

Country	Name	City	State
United Kingdom	University of Dundee Medical School	Dundee	Angus

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Muscle energetics as measured by MR-spectroscopy	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)	24 weeks
Secondary	Short Performance Battery test		24 weeks
Secondary	6-Minute Walk Test		24 weeks
Secondary	Change in Flow Mediated Dilatation		24 weeks
Secondary	Markers of oxidative stress (F2-Isoprostanes)		24 weeks
Secondary	Quality of Life measured by EuroQOL EQ5D questionnaire		24 weeks