[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483033":3},{"organization":4,"outcomesModule":7,"designInfo":103,"detailedDescription":114,"studyPopulation":102,"armGroups":115,"interventions":128,"overallOfficials":102,"centralContacts":139,"locations":146,"responsibleParty":294,"collaborators":296,"id":319,"slug":102,"hasResults":320,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":320,"sex":326,"minAge":327,"maxAge":102,"enrollmentInfo":328,"targetDuration":102,"studyType":331,"phases":332,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":149,"whyStopped":102,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":102},[9],{"measure":10,"description":11,"timeFrame":12},"type 2 diabetes","development of type 2 diabetes defined by fasting glycaemia, oral glucose tolerance test and\u002For HbA1c according to the ADA criteria","by 160 weeks",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98],{"measure":15,"description":16,"timeFrame":12},"medication for diabetes","percentage need for rescue therapy for diabetes",{"measure":18,"description":19,"timeFrame":12},"prediabetes","percentage prediabetes based on fasting glycaemia, oral glucose tolerance test and\u002For HbA1c (ADA criteria)",{"measure":21,"description":22,"timeFrame":12},"normoglycaemia","percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and\u002For HbA1c (ADA criteria)",{"measure":24,"description":25,"timeFrame":12},"BMI","mean BMI (Kg\u002Fm2)",{"measure":27,"description":28,"timeFrame":12},"waist circumference","mean waist circumference (cm)",{"measure":30,"description":31,"timeFrame":12},"waist\u002Fhip ratio","waist\u002Fhip circumference ratio",{"measure":33,"description":34,"timeFrame":12},"5% weight loss","percentage weight loss ≥5%",{"measure":36,"description":37,"timeFrame":12},"10% weight loss","percentage weight loss ≥10%",{"measure":39,"description":40,"timeFrame":12},"15% weight loss","percentage weight loss ≥15%",{"measure":42,"description":43,"timeFrame":12},"body fat percentage","percentage body fat measured by bioelectrical impedance analysis",{"measure":45,"description":46,"timeFrame":12},"HOMA-B index","Beta-cell function measured by the HOMA-B index",{"measure":48,"description":49,"timeFrame":12},"insulinogenic index","Beta-cell function measured by the by the insulinogenic index divided by HOMA-insulin resistance index",{"measure":51,"description":52,"timeFrame":12},"ISSI-2 index","Beta-cell function measured by theby the insulin-secretion sensitivity-2 index",{"measure":54,"description":55,"timeFrame":12},"the Stumvoll index.","Beta-cell function measured by the Stumvoll index.",{"measure":57,"description":58,"timeFrame":12},"Matsuda index","whole body Insulin sensitivity measured by the insulin sensitivity index of Matsuda",{"measure":60,"description":61,"timeFrame":12},"HOMA-IR","the reciprocal of the homeostasis model assessment of insulin resistance (1\u002FHOMA-IR)",{"measure":63,"description":64,"timeFrame":12},"metabolic syndrome","percentage of the metabolic syndrome based on the WHO criteria",{"measure":66,"description":67,"timeFrame":12},"Hypertension","percentage blood pressure ≥140\u002F90mmHg",{"measure":69,"description":70,"timeFrame":12},"heart rate","mean heart rate",{"measure":72,"description":73,"timeFrame":12},"LDL cholesterol","percentage LDL cholesterol ≥100mg\u002Fdl",{"measure":75,"description":76,"timeFrame":12},"Triglycerides","percentage triglycerides ≥150mg\u002Fdl",{"measure":78,"description":79,"timeFrame":12},"hypoglycaemia","percentage with hypoglycaemia (\\\u003C54mg\u002Fdl)",{"measure":81,"description":82,"timeFrame":12},"gastro-intestinal side effects","percentage nausea, vomiting or diarrhea",{"measure":84,"description":85,"timeFrame":12},"self-reported quality of life","health-related quality of life by SF-36 questionnaire",{"measure":87,"description":88,"timeFrame":12},"symptoms of depression","the 20-item Center for Epidemiologic Studies-Depression (CES-D) questionnaire",{"measure":90,"description":91,"timeFrame":12},"anxiety","six-item short-form of the State-Trait Anxiety Inventory questionnaire on anxiety (STAI)",{"measure":93,"description":94,"timeFrame":12},"Diabetes risk perception","Diabetes Risk perception questionnaire, a validated questionnaire to evaluate the perception to develop diabetes",{"measure":96,"description":97,"timeFrame":12},"sleep quality","The validated Pittsburg sleep quality index to evaluate sleep quality",{"measure":99,"description":100,"timeFrame":101},"diabetes remission","diabetes remission rate after treatment stop, defined by fasting, OGTT and\u002For HbA1c","by 172-184 weeks (3-6 months after end of therapy)",null,{"allocation":104,"interventionModel":105,"interventionModelDescription":106,"primaryPurpose":107,"observationalModel":102,"timePerspective":102,"maskingInfo":108},"RANDOMIZED","PARALLEL","multi-centric double blind RCT","PREVENTION",{"masking":109,"maskingDescription":102,"whoMasked":110},"TRIPLE",[111,112,113],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Patient population: Women with a recent history of gestational diabetes (GDM) and persistent glucose intolerance in early postpartum are a particularly high risk group, with about 50% developing type 2 diabetes (T2DM) within 5 years after the delivery. Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) agonist with multiple beneficial metabolic effects, including glucose lowering effect, weight loss and cardiovascular protective effects. The investigators hypothesize that in women with prior GDM and glucose intolerance in early postpartum, treatment with semaglutide will reduce the risk to develop T2DM on the long-term compared to placebo.\n\nIntervention and comparison: Belgian multi-centric double blind RCT with 13 centers to compare semaglutide (once weekly) with placebo in women with a recent history of GDM and glucose intolerance \\[impaired fasting glycaemia (IFG) and\u002For impaired glucose tolerance (IGT)\\] 6weeks - 12 months postpartum. Participants will be 1\u002F1 randomized to semaglutide or placebo on a background of lifestyle measures. Semaglutide will be uptitrated to 1mg\u002Fweek over a 8-week period. Participants will be followed-up for 3 years. Participants will receive a 75g oral glucose tolerance test (OGTT) 3-6 months after the stop of the intervention. Randomization will be stratified according to BMI at the early postpartum visit (\\\u003C25; 25-29.9 and ≥30Kg\u002Fm²).\n\nOutcomes: The primary endpoint is the development of T2DM by 160 weeks defined by fasting plasma glucose, OGTT and\u002For HbA1c according to the ADA criteria. Important secondary endpoints are assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication) and include:\n\nGlycaemic outcomes\n\n* Need for glucose-lowering (rescue) therapy;\n* Frequency of prediabetes based on FPG, OGTT, and\u002For HbA1c;\n* Regression to normoglycaemia. Anthropometric and body composition outcomes\n* Change in body weight, BMI, waist circumference, waist-to-hip ratio;\n* Proportion of participants achieving ≥5%, ≥10%, and ≥15% weight loss;\n* Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®).\n\nInsulin sensitivity and β-cell function\n\n* β-cell function, assessed by HOMA-B, insulinogenic index divided by HOMA-IR, insulin secretion-sensitivity index-2, and the Stumvoll index;\n* Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity) and 1\u002FHOMA-IR, reflecting primarily hepatic insulin sensitivity.\n\nCardiometabolic risk factors\n\n* Prevalence of the metabolic syndrome;\n* Blood pressure (blood pressure ≥140\u002F90 mmHg) and heart rate;\n* Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg\u002FdL or ≥2,6 mmol\u002FL) and triglycerides (≥150 mg\u002FdL or ≥1,7 mmol\u002FL).\n\nPatient-reported outcomes\n\n* Health-related quality of life assessed by SF-36 and EQ-5D-5L;\n* Symptoms of depression (CES-D) and anxiety (short-form STAI);\n* Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire;\n* Sleep quality (Pittsburgh Sleep Quality Index) and food security (short-form HFSSM).\n\nBiomarker outcomes\n\n• Changes in and associations of metabolomic profiles, with cardiometabolic risk and treatment response.\n\nHealth economic outcomes\n\n* Quality-adjusted life years (QALYs);\n* Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo.\n* Health economic analyses are considered exploratory and hypothesis-generating, as the study was primarily powered for the clinical endpoint of incident T2DM rather than economic outcomes.\n\nTo achieve 80% power, we plan a sample size of 252 to detect an estimated 50% reduction in the risk to develop T2DM between both groups, assuming a 30% loss to follow-up during the study.",[116,122],{"label":117,"type":118,"description":119,"interventionNames":120},"semaglutide","ACTIVE_COMPARATOR","semaglutide SC once weekly, up titration over 2 month period to 1mg\u002Fweek (0.25mg once weekly, after 4 weeks 0.5mg once weekly and after 8 weeks the maintenance dose of 1mg once weekly), treatment duration of max. 3 years",[121],"Drug: Semaglutide Pen Injector",{"label":123,"type":124,"description":125,"interventionNames":126},"placebo","PLACEBO_COMPARATOR","placebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years",[127],"Drug: Semaglutide placebo",[129,136],{"type":130,"name":131,"description":132,"armGroupLabels":133,"otherNames":134},"DRUG","Semaglutide Pen Injector","maintenance dose of 1mg SC once weekly",[117],[135],"Ozempic",{"type":130,"name":137,"description":132,"armGroupLabels":138,"otherNames":102},"Semaglutide placebo",[123],[140],{"name":141,"role":142,"phone":143,"phoneExt":144,"email":145},"Katrien Benhalima, MD PhD","CONTACT","16340614","32","katrien.benhalima@uzleuven.be",[147,162,173,181,194,205,213,226,237,248,259,270,281],{"facility":148,"status":149,"city":150,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":158,"contacts":159},"AZORG","RECRUITING","Aalst","Belgium","BE",{"type":154,"coordinates":155},"Point",[156,157],4.0355,50.93604,{"lat":157,"lon":156},[160],{"name":161,"role":142,"phone":102,"phoneExt":102,"email":102},"Katrien Wierckx",{"facility":163,"status":149,"city":164,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"UZA","Antwerp",{"type":154,"coordinates":166},[167,168],4.40026,51.22047,{"lat":168,"lon":167},[171],{"name":172,"role":142,"phone":102,"phoneExt":102,"email":102},"Niels Bochanen",{"facility":174,"status":149,"city":164,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"ZAS",{"type":154,"coordinates":176},[167,168],{"lat":168,"lon":167},[179],{"name":180,"role":142,"phone":102,"phoneExt":102,"email":102},"Ann Verhaegen",{"facility":182,"status":149,"city":183,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"AZ St Jan Brugge","Bruges",{"type":154,"coordinates":185},[186,187],3.22424,51.20892,{"lat":187,"lon":186},[190],{"name":191,"role":142,"phone":192,"phoneExt":102,"email":193},"Sara Vandewalle, MD","003250 45 23 3","SARA.VANDEWALLE@azsintjan.be",{"facility":195,"status":149,"city":196,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Erasme","Brussels",{"type":154,"coordinates":198},[199,200],4.34878,50.85045,{"lat":200,"lon":199},[203],{"name":204,"role":142,"phone":102,"phoneExt":102,"email":102},"Maria Lytrivi",{"facility":206,"status":149,"city":196,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":207,"geoPoint":209,"contacts":210},"UZ Brussel",{"type":154,"coordinates":208},[199,200],{"lat":200,"lon":199},[211],{"name":212,"role":142,"phone":102,"phoneExt":102,"email":102},"Nancy Van Wilder",{"facility":214,"status":149,"city":215,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Jan Yperman","Ieper",{"type":154,"coordinates":217},[218,219],2.88569,50.85114,{"lat":219,"lon":218},[222],{"name":223,"role":142,"phone":224,"phoneExt":102,"email":225},"An Nollet, MD","003257 35 72 70","an.nollet@yperman.net",{"facility":227,"status":149,"city":228,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"AZ Groeninge Kortrijk","Kortrijk",{"type":154,"coordinates":230},[231,232],3.26487,50.82803,{"lat":232,"lon":231},[235],{"name":236,"role":142,"phone":102,"phoneExt":102,"email":102},"Gertjan Vereecke",{"facility":238,"status":149,"city":239,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"UZ Leuven","Leuven",{"type":154,"coordinates":241},[242,243],4.70093,50.87959,{"lat":243,"lon":242},[246],{"name":247,"role":142,"phone":102,"phoneExt":102,"email":102},"Katrien Benhalima",{"facility":249,"status":149,"city":250,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"CHU de Liège","Liège",{"type":154,"coordinates":252},[253,254],5.56749,50.63373,{"lat":254,"lon":253},[257],{"name":258,"role":142,"phone":102,"phoneExt":102,"email":102},"JC Philips",{"facility":260,"status":149,"city":261,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Centre Hospitalier Mouscron","Mouscron",{"type":154,"coordinates":263},[264,265],3.20639,50.74497,{"lat":265,"lon":264},[268],{"name":269,"role":142,"phone":102,"phoneExt":102,"email":102},"Philippe Oriot",{"facility":271,"status":149,"city":272,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Vitaz","Sint-Niklaas",{"type":154,"coordinates":274},[275,276],4.1437,51.16509,{"lat":276,"lon":275},[279],{"name":280,"role":142,"phone":102,"phoneExt":102,"email":102},"Peter Coremans",{"facility":282,"status":149,"city":283,"state":102,"zip":102,"country":151,"countryCode":152,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"AZ Turnhout","Turnhout",{"type":154,"coordinates":285},[286,287],4.94471,51.32254,{"lat":287,"lon":286},[290],{"name":291,"role":142,"phone":292,"phoneExt":102,"email":293},"Joke Cuypers, MD","003214 44 44 32","joke.cuypers@azturnhout.be",{"type":295,"investigatorFullName":102,"investigatorTitle":102,"investigatorAffiliation":102,"oldNameTitle":102,"oldOrganization":102},"SPONSOR",[297,299,301,303,304,306,308,310,312,313,315,317],{"name":298,"class":6},"University Hospital, Antwerp",{"name":300,"class":6},"Universitair Ziekenhuis Brussel",{"name":302,"class":6},"General Hospital Groeninge",{"name":271,"class":6},{"name":305,"class":6},"Centre Hospitalier Universitaire de Liege",{"name":307,"class":6},"Erasme University Hospital",{"name":260,"class":309},"UNKNOWN",{"name":311,"class":6},"Jan Yperman Ziekenhuis",{"name":282,"class":6},{"name":314,"class":6},"AZ Sint-Lucas Brugge",{"name":316,"class":6},"Ziekenhuis aan de Stroom",{"name":318,"class":6},"Onze Lieve Vrouw Hospital","100483033",false,"NCT05569772","Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes","Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT","SERENA","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures\n2. Women aged ≥18 years\n3. Use of highly effective methods of birth control\n4. History of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or \\\u003C24 weeks for early GDM)\n5. Diagnosis of prediabetes between 6 weeks and 12 months postpartum according to ADA criteria (FPG 5.6-6.9 mmol\u002FL, 2-hour OGTT glucose 7.8-11.0 mmol\u002FL and\u002For HbA1c 39-46 mmol\u002Fmol \\[5.7-6.4%\\])\n\nExclusion Criteria:\n\n1. Presence of autoantibodies suggestive of type 1 diabetes, normal glucose tolerance, history of pancreatitis, previous bariatric surgery or planned surgery within two years\n2. Unable to understand and speak Dutch, French or English\n3. Female who is pregnant or intends to become pregnant within the next year\n4. Female who wants to give breastfeeding \\>22 months\n5. Use of medication with significant impact on glycaemia (such as high dose glucocorticoids or metformin)","FEMALE","18 Years",{"count":329,"type":330},252,"ESTIMATED","INTERVENTIONAL",[333],"PHASE3","Gestational diabetes (GDM) is an important contributor to the increasing prevalence of type 2 diabetes (T2DM). Women with glucose intolerance in early postpartum are a particularly high-risk group with about 50% who will develop T2DM within 5 years after the delivery. Moreover, women with a history of GDM progress more rapidly to T2DM compared to women with similarly elevated glucose levels. Early intervention after the index pregnancy is therefore crucial to prevent T2DM. With the SERENA project, the investigators aim to reduce the risk to develop T2DM with the long-acting GLP-1 agonist semaglutide in women with a recent history of GDM and glucose intolerance in early postpartum.",[336],"Glucose Intolerance After a Recent History of Gestational Diabetes",[338,339,340,10,341,117],"gestational diabetes","glucose intolerance postpartum","prevention","GLP-1 agonist","2026-05-28",{"date":344,"type":345},"2026-06-02","ACTUAL",{"date":347,"type":345},"2023-09-14",{"date":349,"type":330},"2029-12",{"name":5,"class":6},13]