Metformin to Augment Low Milk Supply (MALMS) Study

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Low Milk Supply, Pre-diabetes, Insulin Resistance, Suppressed Lactation

In brief

Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not yet diabetic). My progression of research suggests that the same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale randomized trial designed to test for a trend in the hypothesis that metformin is safe and potentially effective in treating low milk supply in insulin resistant and pre-diabetic mothers.

Key facts

Study ID

NCT02179788

Run by

Children's Hospital Medical Center, Cincinnati

People needed

15

Starts

2014-06-01

Expected to finish

2016-07-01

Last updated by the study team

2020-10-19

Who can join

Age: 20 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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