[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654278":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":42,"armGroups":49,"interventions":60,"overallOfficials":42,"centralContacts":66,"locations":72,"responsibleParty":86,"collaborators":42,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":42,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":42,"enrollmentInfo":99,"targetDuration":42,"studyType":102,"phases":103,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":115,"whyStopped":42,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of Massachusetts, Worcester","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Metabolic Syndrome","Metabolic syndrome will be treated as a binary variable. Metabolic syndrome is defined as a cluster of cardiovascular risk factors that is defined as having three or more of the following five criteria: waist circumference over 88 centimeters in women, blood pressure greater than or equal to 130\u002F85 mmHg, fasting triglyceride (TG) level greater than or equal to 150 mg\u002FdL, fasting high-density lipoprotein (HDL) cholesterol level less than 50 mg\u002Fdl and fasting blood sugar greater than or equal to 110 mg\u002FdL.","6 months after randomization",[14,18,22,25,28,31,34,36,39],{"measure":15,"description":16,"timeFrame":17},"Percent Weight Loss","Calculated from measured weight at baseline and from initial prenatal visit weight","3, 6, and 12 months after randomization",{"measure":19,"description":20,"timeFrame":21},"Body Mass Index","Calculated from the height and weight","Baseline, 3, 6, and 12 months after randomization",{"measure":23,"description":24,"timeFrame":21},"Waist Circumference","Standardized anthropometric measurement in centimeters",{"measure":26,"description":27,"timeFrame":21},"Systolic and Diastolic Blood Pressure","Mean blood pressure from 3 automated measurements taken after resting for 5 minutes",{"measure":29,"description":30,"timeFrame":21},"Concentration of Fasting Blood Sugar","Laboratory assay of fasting blood sugar",{"measure":32,"description":33,"timeFrame":21},"Concentration of Triglycerides","Laboratory assay",{"measure":35,"description":33,"timeFrame":21},"Concentration of High Density Lipoprotein (HDL) Cholesterol",{"measure":37,"description":38,"timeFrame":17},"Type 2 Diabetes Mellitus","Diagnosed by a hemoglobin A1c greater than 6.4%",{"measure":40,"description":41,"timeFrame":21},"Concentration of High sensitivity troponin","Laboratory assay assessing cardiac injury",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Semaglutide","EXPERIMENTAL","The intervention\u002Factive arm is semaglutide initiated within 6 weeks of delivery and administered once weekly for 6 months to postpartum individuals following a pregnancy complicated by gestational diabetes mellitus (GDM). Participants randomized to the intervention arm will receive semaglutide in addition to standard postpartum care. Treatment will be initiated using a standardized dose-escalation regimen consistent with the approved prescribing approach to improve tolerability, with dose adjustments or discontinuation based on tolerability and clinical safety.",[55],"Drug: Semaglutide (Wegovy) weekly injection",{"label":57,"type":58,"description":59,"interventionNames":42},"Standard of Care","NO_INTERVENTION","Participants randomized to the control arm will receive standard postpartum care following a pregnancy complicated by gestational diabetes mellitus (GDM). Standard care will include educational materials addressing postpartum diabetes screening, healthy nutrition, physical activity, weight management, and long-term cardiometabolic risk following GDM. Participants will otherwise receive routine clinical care according to their treating providers and will not receive study-provided semaglutide during the 6-month randomized active phase.",[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":42},"DRUG","Semaglutide (Wegovy) weekly injection","The intervention is semaglutide initiated within 6 weeks of delivery and administered once weekly for 6 months to postpartum individuals following a pregnancy complicated by gestational diabetes mellitus (GDM). Participants randomized to the intervention arm will receive semaglutide in addition to standard postpartum care. Treatment will be initiated using a standardized dose-escalation regimen consistent with the approved prescribing approach to improve tolerability, with dose adjustments or discontinuation based on tolerability and clinical safety.",[51],[67],{"name":68,"role":69,"phone":70,"phoneExt":42,"email":71},"Gianna L Wilkie, MD, MSc","CONTACT","508-334-0550","Gianna.Wilkie@umassmemorial.org",[73],{"facility":74,"status":42,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":42},"UMass Memorial","Worcester","Massachusetts","01605","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-71.80229,42.26259,{"lat":84,"lon":83},{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Gianna Wilkie","Assistant Professor of Obstetrics and Gynecology","100654278","phase-2-postpartum-semaglutide-to-reduce-cardiometabolic-risk-after-gestational-diabetes-100654278",false,"NCT07797036","Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus","Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized Trial","Inclusion Criteria:\n\n* Age greater than or equal to 18\n* Postpartum state (delivered within 6 weeks)\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n* a history of acute or chronic pancreatitis\n* personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma\n* diagnosis of pre-gestational diabetes (type 1 or 2 diabetes mellitus)\n* body mass index \\\u003C25 kg\u002Fm2\n* Plan to attempt pregnancy within next 12 months or confirmed pregnancy\n* Known allergy to semaglutide from prior exposure\n* Previous participation in this trial\n* History of suicidal ideation\u002Fattempt in the past 12 months\n* Current or recent diagnosis in the last 12 months of anorexia nervosa, bulimia nervosa, binge eating disorder, or other eating disorder\n* Actively breastfeeding or lactating","FEMALE","18 Years",{"count":100,"type":101},226,"ESTIMATED","INTERVENTIONAL",[104,105],"PHASE2","PHASE3","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.",[108,10],"Gestational Diabetes Mellitus (GDM)",[110,111,112,113,114],"postpartum","gestational diabetes mellitus","metabolic syndrome","GLP-1 receptor agonist","semaglutide","NOT_YET_RECRUITING","2026-09-23",{"date":118,"type":119},"2026-09-28","ACTUAL",{"date":121,"type":101},"2027-09-01",{"date":123,"type":101},"2030-12-31",{"name":5,"class":6},1]