[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720414":3,"trial-entities:NCT07720414":87,"trial-summary:NCT07720414":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":19,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":44,"sex":45,"minimum_age":15,"maximum_age":15,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":60,"locations":64,"central_contacts":74,"overall_officials":84,"references":85,"see_also_links":86},"NCT07720414","26-1234","Effects of GLP-1 RAs on Human Lactation Outcomes","RECRUITING","2028-06","2026-07","2026-07-22","University of Colorado, Denver","OTHER",false,"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.",null,[17,18],"Lactation","Weight Loss",[20,21,22,18],"Breastmilk production","Breastmilk composition","GLP-1","OBSERVATIONAL",[],{"count":26,"type":27},18,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[34],"Breastfeeding mothers prescribed GLP-1 RA therapies",[36,40],{"measure":37,"description":38,"timeFrame":39},"Hourly milk production rate","Milk production rate (in grams per hour) will be assessed using a standardized milk expression protocol.","From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.",{"measure":41,"description":42,"timeFrame":43},"Milk macronutrient composition","Milk macronutrient composition will be assessed using the Miris Human Milk Analyzer.","From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if the dosage is increased.",[],"FEMALE",true,{"inclusion":48,"exclusion":56,"raw_text":59},[49,50,51,52,53,54,55],"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.",[57,58],"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.","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.",[61,62,63],"CHILD","ADULT","OLDER_ADULT",[65],{"facility":66,"status":7,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"University of Colorado Anschutz School of Medicine","Aurora","Colorado","80045","United States",{"lat":72,"lon":73},39.72943,-104.83192,[75,80],{"name":76,"role":77,"phone":78,"email":79},"Jayne F Martin Carli, PhD","CONTACT","303-724-3981","jayne.martincarli@cuanschutz.edu",{"name":81,"role":77,"phone":82,"email":83},"Jacinda M Nicklas, MD, MPH","303-724-9028","jacinda.nicklas@cuanschutz.edu",[],[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[89],"Weaning",[],{"nct_id":4,"found":46,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an observational study, meaning researchers will watch what happens when you take GLP-1 RA medications prescribed by your doctor. It plans to include 18 participants.","completed","GLP-1 RAs and Breastfeeding Study","This observational study is looking at how medications like semaglutide and tirzepatide (called GLP-1 Receptor Agonists, or GLP-1 RAs) affect breast milk production and its nutritional content. These medications are often used for weight loss after pregnancy. Researchers want to know if these drugs increase or decrease how much milk you make, and if they change the fat content or other nutrients in your milk. You could join if you are a breastfeeding mother, remove milk at least four times a day, and are already eligible for an injected GLP-1 RA from your doctor. The study will measure your milk production and composition before and after you start taking the medication. This study is currently unclear on its recruitment status and plans to enroll 18 participants.","Your milk production and composition will be measured from one week before until a maximum of 2 months after beginning GLP-1 RA treatment. This timeframe will restart if your dosage is increased.",126,"You will weigh yourself and report measurements daily. You will also participate in 2-3 morning study visits and provide 1-3 ounces of breast milk per visit.","Not stated in the trial record.",[],"v2"]