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. 2022 Jul 18;12(7):e061823. doi: 10.1136/bmjopen-2022-061823

Table 1.

MET-PREVENT trial schedule of events

Timepoint Prescreening Screen Baseline 1 week (+3 days) after randomisation 1 month (+1 week) after randomisation 2 months (+1 week) after randomisation 3 months (+1 week) after randomisation 4 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 practices X
 Telephone prescreening (verbal consent, demographics, SARC-F tool) for participants who send a positive reply slip X
 Patient information sheet posted to participants who pass prescreen X
 Informed written consent X
 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 confirmation X
 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 assessments X
 Dispensing/posting trial medication X
Biological samples
 Blood and stool X X
Intervention
4 months supply of Metformin hydrochloride 500 mg tablets or matching placebo tablets graphic file with name bmjopen-2022-061823ilf01.jpg
Follow-up
 Confirm medication receipt, ability to open medication bottle, date of first dose X
 Safety blood tests (U&Es, LFTs, glucose, lactate) X X X X
 Adverse event assessments X X X X X X X
 Concomitant Medications X X X X X X X
 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 medication X
 Medication compliance, accountability X

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.