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Not Yet Recruiting 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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07797036). StuddyBuddy aggregates publicly available trial information.