[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648360":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":45,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":10,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Breastfeeding mothers prescribed GLP-1 RA therapies",null,"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\u002Fm2 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\u002Fm2)) and who are committed to sustaining breastfeeding habits (frequency and volume of milk removal) for the duration of the study period.",[13],"Drug: Injected GLP-1 Receptor Agonists and Dual Agonists",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Jayne F Martin Carli, PhD","CONTACT","303-724-3981","jayne.martincarli@cuanschutz.edu",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Jacinda M Nicklas, MD, MPH","303-724-9028","jacinda.nicklas@cuanschutz.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":10},"University of Colorado Anschutz School of Medicine","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-104.83192,39.72943,{"lat":43,"lon":42},{"type":46,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100648360","effects-of-glp-1-ras-on-human-lactation-outcomes-100648360",false,"NCT07720414","Effects of GLP-1 RAs on Human Lactation Outcomes","Inclusion Criteria:\n\n* Breastfeeding mothers of single or multiple infants.\n* Milk removal at least 4x daily\n* Eligible for a GLP-1 RA administered subcutaneously (oral GLP-1 RAs contain absorption enhancers, which may drive accumulation in milk)\n* Access to a breastpump, if needed for maintaining breastfeeding behaviors.\n* Willingness to provide 1-3 oz of breastmilk per study visit.\n* Willingness to track and report body weight daily.\n* Willingness to maintain breastfeeding behaviors for the duration of the study.\n\nExclusion Criteria:\n\n* Currently taking GLP-1 RA medication or other weight loss medication\n* Induced lactation, due to unknowns regarding the durability of the mammary gland's milk production after exogenous stimulation.",true,"FEMALE",{"count":56,"type":57},18,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions the study will address are:\n\n* Does GLP-1 RA-induced weight loss increase or decrease breastmilk production?\n* Does GLP-1 RA-induced weight loss affect the nutritional composition of milk, including milk fat content?\n\nResearchers 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.\n\nParticipants will:\n\n* Weigh themselves and report measurements daily.\n* Participate in 2-3 morning study visits over approx. 2.5-4.5 months (approx. 3-3.5hrs each).\n\nDuring each visit, participants will:\n\n* Use a study provided breastpump to express milk 3 times hourly for measurement of hourly milk production.\n* Provide 1-3 oz of milk for further study.\n* Answer questions about breastfeeding patterns.",[61,62],"Lactation","Weight Loss",[64,65,66,62],"Breastmilk production","Breastmilk composition","GLP-1","2026-07-17",{"date":69,"type":70},"2026-07-22","ACTUAL",{"date":72,"type":57},"2026-07",{"date":74,"type":57},"2028-06",{"name":5,"class":6},1]