Table 1

MET-PREVENT trial schedule of events

TimepointPrescreeningScreenBaseline1 week (+3 days) after randomisation1 month (+1 week) after randomisation2 months (+1 week) after randomisation3 months (+1 week) after randomisation4 months
±2 weeks
Screening, consent and preallocation assessments
 Brief study information sheet and invitation letter posted/given to patients identified via SarcNet Registry, older peoples medicine clinics, day units and rehabilitation facilities and GP practicesX
 Telephone prescreening (verbal consent, demographics, SARC-F tool) for participants who send a positive reply slipX
 Patient information sheet posted to participants who pass prescreenX
 Informed written consentX
 Eligibility assessments (U&Es, LFTs, demographics, medical history, concomitant medication, adverse events, four metre walk speed, 5 x sit to stand time, grip strength)X
 Eligibility confirmationX
 Baseline assessments preallocation (blood glucose and HbA1c, height and weight, bioimpedance, AGE skin fluorescence, physical performance tests (SPPB, grip strength, six min walk), quality of life questionnaires (EQ5D5L, SF-36, Nottingham EADL), frailty screening questions (activity, exhaustion).X
 Allocation (randomisation)—following completion of assessmentsX
 Dispensing/posting trial medicationX
Biological samples
 Blood and stoolXX
Intervention
4 months supply of Metformin hydrochloride 500 mg tablets or matching placebo tabletsEmbedded Image
Follow-up
 Confirm medication receipt, ability to open medication bottle, date of first doseX
 Safety blood tests (U&Es, LFTs, glucose, lactate)XXXX
 Adverse event assessmentsXXXXXXX
 Concomitant MedicationsXXXXXXX
 Follow-up assessments (blood glucose and HbA1c, weight, bioimpedance, AGE skin fluorescence, physical performance tests (SPPB, grip strength, 6 min walk), quality of life questionnaires (EQ5D5L, SF-36, Nottingham EADL), frailty screening questions (activity, exhaustion).X
 Return of unused trial medicationX
 Medication compliance, accountabilityX
  • AGE, advanced glycosylation end; EADL, extended activities of daily living; EQ5D5L, EuroQoL 5 dimension 5 level; GP, general practices; HbA1c, glycated haemoglobin; LFTs, liver function tests; SARC-F, Strength, Assistance, Rise, Climb, Falls; SF-36, short form 36; SPPB, Short Physical Performance Battery; U&Es, creatinine and electrolytes.