Can metformin relieve tibiofemoral cartilage volume loss and knee symptoms in overweight knee osteoarthritis patients? Study protocol for a randomized, double-blind, and placebo-controlled trial

Table 1 Schedule of data collection

	Screening	months
	Screening	0	3	6	12	24
Primary outcomes
Tibiofemoral cartilage volume		✔				✔
WOMAC		✔	✔	✔	✔	✔
Secondary outcomes
Knee pain VAS	✔	✔	✔	✔	✔	✔
Tibiofemoral cartilage defect		✔				✔
Effusion-synovitis volume		✔				✔
Tibiofemoral bone marrow lesion maximum size		✔				✔
Other measurements
Clinical evaluation and history inquiry	✔
Joint space narrowing	✔
Hepatic and renal function	✔			✔	✔	✔
Height	✔
Weight	✔	✔	✔	✔	✔	✔
Hoffa-synovitis		✔				✔
AQoL-4D		✔	✔	✔	✔	✔
PHQ-9		✔	✔	✔	✔	✔
Body composition		✔	✔	✔	✔	✔
Serum cytokines	✔					✔
Foot pain VAS		✔	✔	✔	✔	✔
Low back pain VAS		✔	✔	✔	✔	✔
Concomitant medication		✔	✔	✔	✔	✔
Pill counts		✔	✔	✔	✔	✔
Adverse events		✔	✔	✔	✔	✔

WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, VAS visual analogue scale, AQoL-4D four-dimensional Assessment of Quality of Life, PHQ-9 nine-items Patient Health Questionnaire

ISSN: 1471-2474