ISRCTN87404878已完成未知
Acipimox to improve muscle function and sarcopenia – a feasibility study
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 11 人开始时间: 2021年6月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38417968/ (added 05/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 08/12/2023:
- •1. Age 65 years and over
- •2. Low maximum handgrip strength (<16kg for women, <27kg for men) or 5 times sit to stand >15 seconds
- •3. Walk speed <=0.8 m/s on 4-metre walk test
- •Previous participant inclusion criteria:
- •1. Age 65 years or over
- •2. Low maximum handgrip strength (<16kg for women, <27kg for men)
- •3. Walk speed <=0.8 m/s on 4 metre walk test
排除标准
- •1. General:
- •1.1. Allergy to acipimox or other niacin-related products
- •1.2. Allergy or intolerance of aspirin
- •1.3. Unable to give written informed consent
- •1.4. Currently enrolled in another intervention study (observational studies are permitted)
- •1.5. Currently participating in supervised exercise classes or physiotherapy
- •1.6. Any progressive neurological or malignant condition with life expectancy <6 months
- •2. Safety of Acipimox and Aspirin:
- •2.1. eGFR <45ml/min/1.73m² (a measure of kidney function)
- •2.2. Taking statin medication or fibrate medication
- •2.3. Active peptic ulcer disease or indigestion
- •3. Safety of muscle biopsy and MRI:
- •3.1. Platelets <100x10^9/L at screening (contraindication to muscle biopsy)
- •3.2. Presence of a bleeding tendency or use of oral or injectable anticoagulant medication
- •3.3. Antiplatelet agents other than low dose (75mg once daily) aspirin
- •3.4. Unable to feel quadriceps muscle in leg to locate where to biopsy
- •3.5. Contraindications to MRI scanning (mild claustrophobia is not a contraindication)
- •4. Other causes of skeletal myopathy:
- •4.1. Liver function tests (bilirubin, ALT, alkaline phosphatase) >3x upper limit of normal
- •4.2. Symptomatic (NYHA class II-IV) chronic heart failure (diagnosed according to European Society of Cardiology guidelines)
- •4.3. Severe Chronic obstructive pulmonary disease (GOLD stage IV)
- •4.4. Known myositis or other established myopathy (muscle disease)
- •4.5. Self-reported weight loss of >10% in last 6 months (to exclude significant cachexia)
- •4.6. Known uncontrolled thyrotoxicosis (overactive thyroid disease)
- •4.7. 7.5mg/day or greater prednisolone use (or equivalent) (steroid that can cause muscle weakness)
研究者
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