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MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty - protocol for a double-blind, randomised controlled proof-of-concept trial

Lookup NU author(s): Dr Kate Rennie, Professor Miles WithamORCiD, Penny Bradley, Professor Helen Hancock, Shaun HiuORCiD, Dr Leanne Marsay, Dr Claire McDonald, Laura Robertson, Laura Simms, Dr Alison SteelORCiD, Bryony Storey, Professor James WasonORCiD, Dr Nina WilsonORCiD, Professor Thomas von Zglinicki, Professor Avan SayerORCiD



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN29932357.

Publication metadata

Author(s): Rennie KJ, Witham M, Bradley P, Clegg A, Connolly S, Hancock HC, Hiu S, Marsay L, McDonald C, Robertson L, Simms L, Steel AJ, Steves CJ, Storey B, Wason J, Wilson N, von Zglinicki T, Sayer AAP

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2022

Volume: 12

Issue: 7

Online publication date: 18/07/2022

Acceptance date: 19/06/2022

Date deposited: 28/07/2022

ISSN (print): 2044-6055

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group


DOI: 10.1136/bmjopen-2022-061823

PubMed id: 35851031


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