Metformin to Augment Strength Training Effective Response in Seniors (MASTERS): study protocol for a randomized controlled trial

Table 1 Summary of human subject participation and data collection schedule

Time point	Physical exam and medical history	Blood draw	Oral glucose tolerance test	Physical function testing (SPPB)	Body composition (DXA, CT, and circumferences)	Muscle biopsy	SF-36, PASE, PROMIS modules	Muscle strength and power testing (Biodex, 1RM)	4-day diet record	Physical activity monitoring
Pre-treatment	X	X	X	X	X	X	X	Familiarization	X	X
2 weeks of metformin or placebo treatment only (prior to progressive resistance training, PRT)
Week 2 (pre-PRT)		X				X		X
Week 4								X
Week 9 (mid-PRT)		X (CMP only)						X
Week 16 (post-PRT)		X	X	X	X	X	X	X	X	X
Long-term follow-up (week 26 and week 52)				X			X	X		X

Each individual can participate in the study for approximately 1 year. Participation includes pre-treatment, medication- or placebo-only ramping period, 14 weeks of PRT, and optional post-training follow-up at 10 weeks (week 26) and 36 weeks (week 52) post-training. Once subjects start medication or placebo treatment, they continue taking the treatment until post-training outcomes are assessed. The scheduling timeline is approximate and allows for the scheduling needs of the subjects and study staff.
CMP comprehensive metabolic panel, SPPB Short Physical Performance Battery, DXA dual-energy X-ray absorptiometry, CT computed tomography, SF-36 Short-Form 36, PASE Physical Activity Survey for the Elderly, PROMIS Patient-Reported Outcomes Measurement Information System, 1RM one repetition maximum

ISSN: 1745-6215