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
Qualifiers
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 design
Treatments tested in this trial
- Injected GLP-1 Receptor Agonists and Dual Agonists
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov