Clinical trial

Effects of GLP-1 RAs on Human Lactation Outcomes

Recruiting now · Not applicable · 1 countries · Registry ID NCT07720414

Recruiting nowNot applicableObservational

What this study is about

There is increasing interest in using GLP-1 Receptor Agonist (GLP-1 RA) medications after pregnancy. This study is designed to determine if these medications affect breastmilk production or the nutritional makeup of breastmilk. The main questions the study will address are: * Does GLP-1 RA-induced weight loss increase or decrease breastmilk production? * Does GLP-1 RA-induced weight loss affect the nutritional composition of milk, including milk fat content? Researchers will assess milk production rates before and after mothers begin taking injected GLP-1 RA medications to decrease their body weight. Weight loss will be confirmed with 7-day body weight averages. Participants will: * Weigh themselves and report measurements daily. * Participate in 2-3 morning study visits over approx. 2.5-4.5 months (approx. 3-3.5hrs each). During each visit, participants will: * Use a study provided breastpump to express milk 3 times hourly for measurement of hourly milk production. * Provide 1-3 oz of milk for further study. * Answer questions about breastfeeding patterns.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexFemale

Healthy volunteersAccepted

ConditionLactation, Weight Loss

Full registry criteria

Inclusion Criteria: * Breastfeeding mothers of single or multiple infants. * Milk removal at least 4x daily * Eligible for a GLP-1 RA administered subcutaneously (oral GLP-1 RAs contain absorption enhancers, which may drive accumulation in milk) * Access to a breastpump, if needed for maintaining breastfeeding behaviors. * Willingness to provide 1-3 oz of breastmilk per study visit. * Willingness to track and report body weight daily. * Willingness to maintain breastfeeding behaviors for the duration of the study. Exclusion Criteria: * Currently taking GLP-1 RA medication or other weight loss medication * Induced lactation, due to unknowns regarding the durability of the mammary gland's milk production after exogenous stimulation.

Treatments and study arms

Injected GLP-1 Receptor Agonists and Dual Agonists

Drug

Participants are prescribed this medication by their care provider(s) as part of their postnatal clinical care, including but not limited to semaglutide and tirzepatide. The investigators do not provide, manage, or assign the medication.

Primary outcomes

Hourly milk production rateFrom one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.

Milk production rate (in grams per hour) will be assessed using a standardized milk expression protocol.

Milk macronutrient compositionFrom one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if the dosage is increased.

Milk macronutrient composition will be assessed using the Miris Human Milk Analyzer.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz School of Medicine🇺🇸 Aurora, Colorado, United States

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