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NCT07797036
Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus
Conditions: Gestational Diabetes Mellitus (GDM), Metabolic Syndrome
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 226
Sponsor: University of Massachusetts, Worcester
Location: UMass Memorial Worcester Massachusetts
Summary
This is an effectiveness-implementation Hybrid Type 1 study using a randomized clinical trial design to evaluate the effectiveness and potential real-world integration of immediate postpartum semaglutide following a pregnancy complicated by gestational diabetes mellitus (GDM). A total of 226 postpartum individuals with recent GDM will be randomized 1:1 to semaglutide or standard postpartum care for a 6-month active treatment phase. The primary effectiveness outcome, development of metabolic syndrome, will be assessed at 6 months postpartum. Participants will subsequently enter a 6-month maintenance phase, during which semaglutide continuation, discontinuation, or initiation will reflect patient preferences, clinical decision-making, medication access, and insurance coverage.
Eligibility Criteria
Inclusion Criteria:
* Age greater than or equal to 18
* Postpartum state (delivered within 6 weeks)
* Ability and willingness to provide informed consent
Exclusion Criteria:
* a history of acute or chronic pancreatitis
* personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
* diagnosis of pre-gestational diabetes (type 1 or 2 diabetes mellitus)
* body mass index \
Source: ClinicalTrials.gov (NCT07797036). StuddyBuddy aggregates publicly available trial information.