[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626481":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":29,"responsibleParty":48,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University of Ulm","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant women + fathers of the unborn child",null,"Metabolic and epigenetic characterization",[13],"Other: Metabolic and epigenetic characterization of parents ans fetuses",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Metabolic and epigenetic characterization of parents ans fetuses","Pregnant women will undergo an oral glucose tolerance test to characterize metabolism and assess the presence of gestational diabetes. Moreover, they will undergo blood sampling to assess the mothers' epigenetic signatures and the fetal epigenetic signatures based on circulating fetal cell-free DNA.\n\nFathers will undergo (if possible fasting) blood sample to characterize metabolism and epigenetic signatures",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Martin Heni, Prof, MD","CONTACT","+49 731 500 44505","martin.heni@uniklinik-ulm.de",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Sabrina Wangler","+49 731 500 44782","sabrina.wangler@uniklinik-ulm.de",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ulm University Hospital","RECRUITING","Ulm","Baden-Wurttemberg","89081","Germany","DE",{"type":39,"coordinates":40},"Point",[41,42],9.99155,48.39841,{"lat":42,"lon":41},[45,47],{"name":46,"role":22,"phone":23,"phoneExt":10,"email":24},"Martin Heni, Prof.",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Martin Heni","Prof. Dr. med Martin Heni","100626481","imprinting-in-metabolic-diseases---identifying-epigenetic-mechanisms-in-human-gestational-diabetes-through-cell-free-dna-100626481",false,"NCT07436195","Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA","Epi_GDM","Inclusion Criteria:\n\n* Pregnant women between 20 and 28 weeks of gestation\n* The father of the child is known and willing to participate in the study\n* No known underlying medical conditions in either parent\n* No fetal abnormalities detected in first-trimester screening, detailed fetal anatomy ultrasound, non-invasive prenatal testing (NIPT), or any additional prenatal examinations performed, if applicable\n* No known underlying diseases\n* Understanding and voluntary signing of a consent form before study- related examinations\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Type 1 or type 2 diabetes mellitus\n* Pharmacological treatment affecting blood glucose levels (e.g., steroids, insulin)\n* Endocrine disorders (e.g., hyperthyroidism, polycystic ovary syndrome \\[PCOS\\])\n* Current depression or other psychiatric disorders\n* Eating disorders\n* Regular use of medication during pregnancy\n* Pre-existing cardiovascular disease\n* Drug and\u002For alcohol abuse\n* Estimated glomerular filtration rate (eGFR) \\\u003C 60 ml\u002Fmin\u002F1.73 m²\n* C-reactive protein \\> 10 mg\u002Fl\n* Transaminase elevation of 2 times the upper norm\n* No consent to be informed about incidentally discovered pathological findings\n* Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.",true,"ALL","18 Years",{"count":63,"type":64},80,"ESTIMATED","OBSERVATIONAL","This clinical trials aims to investigate the impact of parental metabolism during pregnancy on fetal epigenetic signatures.\n\nThe metabolic profiles of both parents will be evaluated through a blood sample collected from the father and an oral glucose tolerance test administered to the pregnant mother. Additionally, epigenetic signatures will be assessed using parental blood samples. Fetal epigenetic signatures can be identified by analyzing fetal cell-free DNA that circulates in the mother's bloodstream.",[68],"Gestational Diabetes Mellitus (GDM)",[70,71,72,73,74],"epigenetics","pregnancy","parental metabolism","Cell-free DNA","gestational diabetes","2026-03-31",{"date":77,"type":78},"2026-04-07","ACTUAL",{"date":80,"type":78},"2026-03-30",{"date":82,"type":64},"2028-07-01",{"name":5,"class":6},1]