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Effects of GLP-1 RAs on Human Lactation Outcomes

Recruitingn/aAges any - anyFemaleUniversity of Colorado, Denver
NCT07720414 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 provid

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📋 Eligibility rules (as published)
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.
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What it tests

  • Injected GLP-1 Receptor Agonists and Dual Agonists
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Where

1 site
University of Colorado Anschutz School of Medicine
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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