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Effects of GLP-1 RAs on Human Lactation Outcomes

RECRUITINGSponsored by University of Colorado, Denver
Actively Recruiting
SponsorUniversity of Colorado, Denver
Started2026-07
Est. completion2028-06
Eligibility
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Sex: FEMALEHealthy volunteers accepted
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.

Conditions2

LactationWeight Loss

Interventions1

Locations1 site

University of Colorado Anschutz School of Medicine
Aurora, Colorado, 80045

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