Metformin to Augment Low Milk Supply (MALMS) Study

Inclusion Criteria among mother-infant dyads:

Stage 1 Criteria (for participation in baseline measurement phase):

• identified with low milk supply by a Cincinnati-area IBCLC
• mother denies obvious cause of low milk supply such as pituitary disorder, breast surgery, severe lack of breast emptying ( 37 weeks gestation) infant
• mother free of breast and nipple infections
• mother lives within study catchment area
• mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
• mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during follow up measurements (2-4 weeks) as was consumed during the baseline measurements
• mother not currently taking a prescription medication that may affect the hormones of lactation and not planning to initiate any such drug for at least the next 2-4 weeks.
• mother has established pediatric care for the infant

Stage 2 maternal inclusion criteria (among those who meet Stage 1 criteria, to continue with enrollment into randomized controlled trial, goal, N=30 with replacement for non-completers to at least two weeks):

• successful completion of baseline measurements (involving 24-hour test weighing of milk output and undergoing baseline measurements at the clinical research center, including providing fasting blood samples)
• body mass index is >19.0 kg/m2 (i.e., not underweight)
• evidence of likely insulin resistance, based on at least one of the following: mean fasting plasma glucose between 95.0 - 125.0 g/dL, inclusive; abdominal obesity; history of polycystic ovary syndrome; or history of gestational diabetes
• estimated glomerular filtration rate > 60 mL/min
• liver function in normal range (AST <= 37 U/L, ALT < 87 U/L, and total bilirubin <= 1.1 mg/dL
• willingness to continue trying to lactate for the next 2-4 weeks
• health history does not reveal illness/treatments for which metformin is contraindicated
• participant is not currently being treated with metformin

Eligibility criteria for enrollment into abundant milk supply comparison group (goal, N=30, will be compared in baseline measurements).

Inclusion criteria

• exclusively feeding mother's own milk to infant, and presenting to Cincinnati area IBCLC with breastfeeding question or problem unrelated to milk supply
• mother at least 20 years of age
• infant is between 1 week and 2 calendar months old
• mother gave birth to a single, term infant
• mother free of breast and nipple infections
• mother lives within study catchment area
• mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
• mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during baseline measurements
• mother willing to avoid prescription medication that may affect the hormones of lactation