No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Female
Study type
Observational
Participants needed
18 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for breastfeeding mothers to see how GLP-1 medications after pregnancy affect breastmilk. Participants will weigh themselves daily and visit the study site a few times over a few months to provide milk samples and answer questions about breastfeeding.
Are You a Good Fit for This Trial?
You may be able to join if
I am a breastfeeding mother of one or more infants.
I remove milk from my breasts at least 4 times a day.
I can use GLP-1 RA medication given by injection.
I have access to a breastpump if needed.
I am willing to provide 1-3 ounces of breastmilk at each visit.
I am willing to track and report my body weight daily.
I will maintain my breastfeeding behaviors throughout the study.
You may not be able to join if
I am currently taking a GLP-1 RA or other weight loss medications.
I have induced lactation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Status
Eligibility Criteria
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 b…
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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