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临床试验/NCT01550107
NCT01550107已完成4 期

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

University of Dundee1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
124
试验地点
1
主要终点
Improvement in Muscle energetics as measured by MR-spectroscopy

研究概览

简要总结

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

详细描述

this section will be completed once the study is officially recruiting

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Allopurinol

Active Comparator

Allopurinol 600mg tablets

干预措施: Allopurinol (Drug)

Lactose tablets

Placebo Comparator

Placebo Lactose tablets

干预措施: Lactose tablets (Drug)

结局指标

主要结局

Improvement in Muscle energetics as measured by MR-spectroscopy

时间窗: 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)

次要结局

  • Change in Flow Mediated Dilatation(24 weeks)
  • Markers of oxidative stress (F2-Isoprostanes)(24 weeks)
  • Quality of Life measured by EuroQOL EQ5D questionnaire(24 weeks)
  • Short Performance Battery test(24 weeks)
  • 6-Minute Walk Test(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jacob George

Chief Investigator

University of Dundee

研究点 (1)

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