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 | ||||||||
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.