15
Participants
Start Date
June 30, 2014
Primary Completion Date
July 31, 2016
Study Completion Date
July 31, 2016
Standard care
Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump (provided by study).
Metformin
"The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~* Days 1-7, take one 750 mg capsule with evening meal (750 mg/day)~* Days 8-14, take three 500 mg capsule with evening meal (1500 mg/day)~* Days 14-28 (or through completion of post-intervention data collection), take four 500 mg capsules with evening meal (2000 mg/day)~Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator.~The trial duration is 28 days (with a +/- 3 day cushion)"
Placebo
"The placebo arm will be consuming methylcellulose USP Powder encapsulated in #00 opaque capsules (supplied by PCCA, Houston TX) for 4 weeks according to the following schedule:~* Days 1-7, take 1 capsule with evening meal~* Days 8-14, take 3 capsules with evening meal~* Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal~Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator."
Cincinnati Children's Hospital Medical Center, Cincinnati
University of Cincinnati
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER