[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637978":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":37,"locations":46,"responsibleParty":92,"collaborators":96,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":10,"studyType":117,"phases":10,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",[8,13,16],{"label":9,"type":10,"description":10,"interventionNames":11},"Controls",null,[12],"Diagnostic Test: Oral Fat Load Test",{"label":14,"type":10,"description":10,"interventionNames":15},"Prediabetics",[12],{"label":17,"type":10,"description":10,"interventionNames":18},"Diabetics",[12],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Oral Fat Load Test","After a 12-hour overnight fast, each participant will be given a sugar-free mascarpone cream containing 75 g of fat.\n\nBlood samples will be collected before (OFL Time -1 minute) and 1 (OFL Time +1 hour), 2 (OFL Time +2 hours), 3 (OFL Time +3 hours), 4 (OFL Time +4 hours), and 6 (OFL Time +6 hours) hours after the OFL.",[9,17,14],[26,30,34,35],{"name":27,"affiliation":28,"role":29},"Angelina Passaro, Degree in Medicine and Surgery","University Hospital of Ferrara \"Sant'Anna\"","STUDY_CHAIR",{"name":31,"affiliation":32,"role":33},"Luca Catapano, Degree in Medicine and Surgery","Azienda USL Ferrara","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":33},{"name":27,"affiliation":28,"role":36},"STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Fabiola Castaldo, Pharmacy","CONTACT","+39 3348330516","fabiola.castaldo@unife.it",{"name":44,"role":40,"phone":10,"phoneExt":10,"email":45},"Juana M Sanz Molina, Chemistry","szj@unife.it",[47,72],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University Hospital \"Sant'Anna\" of Ferrara","RECRUITING","Ferrara","44124","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],11.62057,44.83804,{"lat":58,"lon":57},[61,62,65,67,68,70],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},"Juana Maria Sanz Molina, Chemistry Degree","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":10,"phoneExt":10,"email":10},"Domenico Sergi, Nutritional science",{"name":27,"role":33,"phone":10,"phoneExt":10,"email":10},{"name":69,"role":64,"phone":10,"phoneExt":10,"email":10},"Edoardo Dalla Nora, Degree in Medicine and Surgery",{"name":71,"role":64,"phone":10,"phoneExt":10,"email":10},"Simona Colombari, Degree in Dietetics",{"facility":73,"status":49,"city":74,"state":50,"zip":75,"country":52,"countryCode":53,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Nucleo di Cure Primarie di Poggio Renatico - Medicina di Gruppo Poggio Rete Salute Via Salvo D'Acquisto, 1\u002Fa","Poggio Renatico","44023",{"type":55,"coordinates":77},[78,79],11.48695,44.76581,{"lat":79,"lon":78},[82,86,89,90],{"name":83,"role":40,"phone":84,"phoneExt":10,"email":85},"Luca Catapano, Medicine and Surgery","+39 3384838817","l.catapano@gmail.com",{"name":87,"role":40,"phone":88,"phoneExt":10,"email":10},"Eleonora Petrucci, Medicine and Surgery","+39 3461812406",{"name":31,"role":33,"phone":10,"phoneExt":10,"email":10},{"name":91,"role":64,"phone":10,"phoneExt":10,"email":10},"Eleonora Petrucci, Degree in Medicine and Surgery",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Angelina Passaro","Professor",[97,98,100,102],{"name":5,"class":6},{"name":99,"class":6},"S. Anna Hospital",{"name":32,"class":101},"OTHER_GOV",{"name":103,"class":6},"Università degli Studi di Ferrara","100637978","triglyceride-rich-lipoproteins-and-inflammatory-cytokines-after-oral-fat-loading-as-potential-early-biomarkers-of-the-risk-of-progression-towards-diabetes-and-development-of-complications-lipinfat-diabetes-study-100637978",false,"NCT07602023","Triglyceride-rich LIPoproteins and INflammatory Cytokines After Oral FAT Loading as Potential Early Biomarkers of the Risk of Progression Towards DIABETES and Development of Complications. LIPINFAT Diabetes Study.","LIPINFAT","Inclusion Criteria:\n\n* Males and females aged 50-70 years\n* BMI between 25-30 kg\u002Fm2\n* HbA1c ≤7% for T2D\n* HbA1c ≤6.5% for prediabetes\n* HbA1c ≤5.7% for controls\n* Signed Project Information and Informed Consent Form\n* Signed Data Processing Consent Form\n\nExclusion Criteria:\n\n* Lipid-lowering therapy with ezetimibe, fenofibrate, omega-3 fatty acids, or other drugs that can interfere with lipoprotein absorption and metabolism\n* Chronic Kidney Disease (CKD) with estimated glomerular filtration rate (eGFR) \\\u003C60 ml\u002Fmin and renal impairment (e.g., uACR ≥30 mg\u002Fmmol) for 3 months or more\n* Secondary or syndromic forms of obesity\n* Patients on insulin therapy\n* All acute and chronic conditions that, in the opinion of the investigators, may cause bias.\n* Hospitalization for acute illness or major surgery in the last 6 months\n* Patients on stable therapy for less than 3 months\n* Allergy or intolerance to one or more components of the meal used in the protocol\n* Pregnancy or breastfeeding\n* Habitual consumption of alcoholic beverages (\\>20 g\u002Fday for females and \\>30 g\u002Fday for males) or unwillingness to abstain from alcoholic beverages during the study run-in period\n* All subjects who do not consent to participate in the study","ALL","50 Years","70 Years",{"count":115,"type":116},150,"ESTIMATED","OBSERVATIONAL","The aim of the study is to evaluate whether the Oral Fat Loading Test (OFLT) determines a different response in terms of the quantity, quality, and kinetics of triglyceride-rich lipoproteins in subjects with T2D, prediabetics, and control subjects, and whether triglyceride-rich lipoproteins and inflammatory cytokines after OFLT are potential early biomarkers of the risk of progression to diabetes and the development of complications in a general practice setting.\n\nTo address these questions, a hybrid cohort study was designed by identifying three groups of subjects: T2D and prediabetics (exposed and near-exposed) and control subjects (unexposed).",[120],"Prediabetes \u002F Type 2 Diabetes",[122,123,124,125,126,127],"Prediabetes, Type 2 diabetes","Oral Fat Load test","Tryglicerides","Cytokines","lipoproteins","VLDL","2026-05-14",{"date":130,"type":131},"2026-05-22","ACTUAL",{"date":133,"type":131},"2024-05-14",{"date":135,"type":116},"2028-05-14",{"name":94,"class":6},2]