Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.
NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
BMJ Open. 2022 Jul 18;12(7):e061823. doi: 10.1136/bmjopen-2022-061823.
Skeletal muscle dysfunction is central to both sarcopenia and physical frailty, which are associated with a wide range of adverse outcomes including falls and fractures, longer hospital stays, dependency and the need for care. Resistance training may prevent and treat sarcopenia and physical frailty, but not everyone can or wants to exercise. Finding alternatives is critical to alleviate the burden of adverse outcomes associated with sarcopenia and physical frailty. This trial will provide proof-of-concept evidence as to whether metformin can improve physical performance in older people with sarcopenia and physical prefrailty or frailty.
MET-PREVENT is a parallel group, double-blind, placebo-controlled proof-of-concept trial. Trial participants can participate from their own homes, including completing informed consent and screening assessments. Eligible participants with low grip strength or prolonged sit-to-stand time together with slow walk speed will be randomised to either oral metformin hydrochloride 500 mg tablets or matched placebo, taken three times a day for 4 months. The recruitment target is 80 participants from two secondary care hospitals in Newcastle and Gateshead, UK. Local primary care practices will act as participant identification centres. Randomisation will be performed using a web-based minimisation system with a random element, balancing on sex and baseline walk speed. Participants will be followed up for 4 months post-randomisation, with outcomes collected at baseline and 4 months. The primary outcome measure is the four metre walk speed at the 4-month follow-up visit.
The trial has been approved by the Liverpool NHS Research Ethics Committee (20/NW/0470), the Medicines and Healthcare Regulatory Authority (EudraCT 2020-004023-16) and the UK Health Research Authority (IRAS 275219). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.
ISRCTN29932357.
骨骼肌功能障碍是肌肉减少症和身体虚弱的核心，它们与广泛的不良后果相关，包括跌倒和骨折、住院时间延长、依赖和需要护理。抗阻力训练可能预防和治疗肌肉减少症和身体虚弱，但并非每个人都能或愿意进行锻炼。寻找替代方法对于减轻与肌肉减少症和身体虚弱相关的不良后果负担至关重要。这项试验将提供概念验证证据，证明二甲双胍是否可以改善患有肌肉减少症和身体虚弱前期或虚弱的老年人的身体表现。
MET-PREVENT 是一项平行组、双盲、安慰剂对照的概念验证试验。试验参与者可以在家中参与，包括完成知情同意和筛选评估。符合低握力或延长坐站时间以及缓慢步行速度标准的合格参与者将被随机分配到口服盐酸二甲双胍 500mg 片剂或匹配的安慰剂组，每天服用三次，持续 4 个月。该试验的招募目标是来自英国纽卡斯尔和盖茨黑德的两家二级保健医院的 80 名参与者。当地的初级保健诊所将作为参与者识别中心。随机分组将使用基于网络的最小化系统进行，该系统具有随机元素，按性别和基线步行速度平衡。参与者将在随机分组后随访 4 个月，在基线和 4 个月时收集结果。主要结局测量指标是 4 个月随访时的 4 米步行速度。
该试验已获得利物浦国民保健制度研究伦理委员会（20/NW/0470）、药品和医疗保健监管局（EudraCT 2020-004023-16）和英国健康研究局（IRAS 275219）的批准。结果将提供给参与者、他们的家人、患有肌肉减少症的患者、公众、地区和国家临床团队以及国际科学界。
ISRCTN29932357。
