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Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Breastfeeding mothers prescribed GLP-1 RA therapies Breastfeeding mothers who have been prescribed, but have not started, an injected GLP-1RA (these patients have an indication for GLP-1 RA treatment (BMI ≥27 kg/m2 with at least one comorbidity (prediabetes, diabetes, metabolic syndrome, obstructive sleep apnea, hypertension, dyslipidemia, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatohepatitis, atrial fibrillation, venous thromboembolic disease, osteoarthritis, polyendocrine metabolic ovarian syndrome), or BMI ≥30 kg/m2)) and who are committed to sustaining breastfeeding habits (frequency and volume of milk removal) for the duration of the study period.
  • Drug: Injected GLP-1 Receptor Agonists and Dual Agonists
    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.

Recruiting Locations

University of Colorado Anschutz School of Medicine
Aurora, Colorado 80045

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Jayne F Martin Carli, PhD
303-724-3981
jayne.martincarli@cuanschutz.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.