Metformin to prevent progression of sarcopenia and frailty for older people – a randomised controlled proof of concept trial
Frailty and sarcopenia in older people
Participants will be randomised 1:1 into the metformin or placebo arms using a web-based randomisation system. They will receive metformin hydrochloride 500 mg or matching placebo three times a day for 4 months. Assessments will be conducted at baseline and 4 months (all outcomes) with an additional safety assessment visit at 1 month.
1. Aged 65 years or over 2. Low maximum handgrip strength (<16 kg for women, <27 kg for men) 3. Walk speed <0.8 m/s on 4-m walk test
1. Diabetes mellitus (type 1 or type 2) 2. eGFR <45 ml/min/1.73 m2 by MDRD4 or CKD-EPI equation 3. History of diarrhoeal illness within the last 3 months (>48 h of Bristol stool chart grade 6 or 7 ) 4. Alcohol intake >21 units/week (women) or >35 units/week (men) 5. Symptomatic chronic heart failure, diagnosed according to European Society of Cardiology guidelines (asymptomatic left ventricular systolic dysfunction will not be an exclusion criterion) 6. Liver function tests (bilirubin, alanine aminotransferase or alkaline phosphatase) >3x upper limit of normal 7. Oral steroid dose >7.5 mg prednisolone equivalent per day 8. Unable to mobilise without human assistance 9. Life expectancy of <3 months as adjudicated by the local investigator 10. Unable to give written informed consent 11. Previous intolerance of metformin or taking metformin for another condition 12. Currently participating in, or participated within 30 days, another intervention study (observational studies and registries are permitted)