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 |
|
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| 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.