Metformin and physical performance in older people with probable sarcopenia and physical prefrailty or frailty in England (MET-PREVENT): a double-blind, randomised, placebo-controlled trial
Abstract
BACKGROUND
Metformin has effects on multiple biological systems relevant to ageing and has been posited as a candidate therapy for sarcopenia and physical frailty. We aimed to test the efficacy and safety of metformin, a candidate geroprotector, to improve physical performance in older people with probable sarcopenia and physical prefrailty or frailty.
METHODS
In this double-blind, randomised, parallel-group, placebo-controlled trial (MET-PREVENT), participants aged 65 years and older with a 4-m walk speed of less than 0·8 m/s and probable sarcopenia, characterised by low handgrip strength (<16 kg for women and <27 kg for men) or five times sit-to-stand time of longer than 15 s (or inability to complete five sit-to-stands) were recruited from primary care and hospital clinics in Gateshead and Newcastle, UK. Participants were randomly assigned (1:1), via a web-based system with minimisation to ensure balance by sex and baseline 4-m walk speed, to receive either 500 mg oral metformin or matching placebo three times a day for 4 months. The primary outcome was the adjusted between-group difference in 4-m walk speed at 4 months. The primary outcome was analysed in the intention-to-treat population (ie, all participants randomly assigned to treatment) who had complete data, and safety was assessed in all participants who received at least one dose of study treatment. This study is registered with the ISRCTN registry, ISRCTN29932357, and is now complete.
FINDINGS
Between Aug 1,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 72 participants or records.
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