Effects of GLP-1 RAs on Human Lactation Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorUniversity of Colorado, Denver
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Breastfeeding mothers willing to attend study study visits in Aurora, CO.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Injected GLP-1 Receptor Agonists and Dual Agonists
DrugParticipants 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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Breastfeeding mothers prescribed GLP-1 RA therapies1 intervention
Trial outcomes
Primary outcomes
1
Hourly milk production rate
Milk production rate (in grams per hour) will be assessed using a standardized milk expression protocol.
Time frame
From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.2
Milk macronutrient composition
Milk macronutrient composition will be assessed using the Miris Human Milk Analyzer.
Time frame
From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if the dosage is increased.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov