[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613763":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":149,"collaborators":24,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":153,"sex":159,"minAge":160,"maxAge":24,"enrollmentInfo":161,"targetDuration":24,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":178,"whyStopped":24,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Collaborative care pathways group","EXPERIMENTAL","Collaborative development of a care pathway for the implementation of a systematic and standardized screening for hepatic AF in patients with T2D in private diabetes clinics.\n\nThe care pathway will include calculation of the FIB-4 score and transient elastography measurement performed in diabetes clinics if FIB-4≥1.30, in accordance with the recommendations of the French Association for the Study of the Liver (AFEF) and the European Association for the Study of the Liver (EASL).",[13],"Procedure: Collaborative care pathways group",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group without intervention","Current clinical routine practice with no specific intervention",[18],"Procedure: Control group without intervention",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","CO-CONSTRUCTION OF THE CARE PATHWAY:\n\nParticipatory approach according to scientific literature, professional practices, and experience of both healthcare providers and patients.\n\nEstablishment of a working group (hospital endocrinologists, hepatologists, private practice diabetologists, representatives of patients with diabetes followed in the participating centers) to define implementation modalities, professional training, communication and information transfer between professionals, and to ensure a smooth care pathway without overloading the health system .\n\nIMPLEMENTATION:\n\nDefinition of patient care pathway Training of private diabetologists to integrate FIB-4 and TE measurement into their practices Provision of the FibroScan® Monitoring of patients included in the screening program and of the number of TE measurements performed Validation of TE measurements ≥ 8 kPa in a specialized center Definition of referral procedures for patients towards the specialized center",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Hepatic AF screening in patients with T2D in private diabetes clinics according to routine care",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Cyrielle CAUSSY, MD, PhD","CONTACT","+33 4 78 86 44 48","cyrielle.caussy@chu-lyon.fr",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":24},"Dominique DELAUNAY, PhD","+33 4 72 11 00 64",[38,55,68,76,86,96,106,114,123,136],{"facility":39,"status":24,"city":40,"state":24,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Diabetology private center","Caluire-et-Cuire","69300","France","FR",{"type":45,"coordinates":46},"Point",[47,48],4.8464,45.79462,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":53,"phoneExt":24,"email":54},"Guillaume TREIBER","+ 33 9 73 06 04 03","drtreiber.endocrinologie@gmail.com",{"facility":39,"status":24,"city":56,"state":24,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Lyon","69001",{"type":45,"coordinates":59},[60,61],4.84789,45.74906,{"lat":61,"lon":60},[64],{"name":65,"role":31,"phone":66,"phoneExt":24,"email":67},"Annie CLAVIER, Doctor","+33 4 72 41 70 02","aclavier001@gmail.com",{"facility":39,"status":24,"city":56,"state":24,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},{"type":45,"coordinates":70},[60,61],{"lat":61,"lon":60},[73],{"name":74,"role":31,"phone":66,"phoneExt":24,"email":75},"Marine BENOIT","dr.marine.benoit@gmail.com",{"facility":39,"status":24,"city":56,"state":24,"zip":77,"country":42,"countryCode":43,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"69002",{"type":45,"coordinates":79},[60,61],{"lat":61,"lon":60},[82],{"name":83,"role":31,"phone":24,"phoneExt":84,"email":85},"Laura BOGENMANN","+33 4 78 92 41","drbogenmann@gmail.com",{"facility":39,"status":24,"city":56,"state":24,"zip":87,"country":42,"countryCode":43,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"69005",{"type":45,"coordinates":89},[60,61],{"lat":61,"lon":60},[92],{"name":93,"role":31,"phone":94,"phoneExt":24,"email":95},"CLARET-GARDETTE Mathilde","+33 6 13 65 00 10","docteurmcg@gmail.com",{"facility":39,"status":24,"city":56,"state":24,"zip":97,"country":42,"countryCode":43,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"69009",{"type":45,"coordinates":99},[60,61],{"lat":61,"lon":60},[102],{"name":103,"role":31,"phone":104,"phoneExt":24,"email":105},"Audrey VILLARD","+33 6 72 08 19 88","dr.audreyvillard@gmail.com",{"facility":39,"status":24,"city":56,"state":24,"zip":97,"country":42,"countryCode":43,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},{"type":45,"coordinates":108},[60,61],{"lat":61,"lon":60},[111],{"name":112,"role":31,"phone":66,"phoneExt":24,"email":113},"JONCOUR MILLS Gwendoline","drjoncourmills@gmail.com",{"facility":39,"status":24,"city":56,"state":24,"zip":97,"country":42,"countryCode":43,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},{"type":45,"coordinates":116},[60,61],{"lat":61,"lon":60},[119],{"name":120,"role":31,"phone":121,"phoneExt":24,"email":122},"Sylvie RODE","+33 4 69 98 20 87","secretariat@endoclyon.fr",{"facility":39,"status":24,"city":124,"state":24,"zip":125,"country":42,"countryCode":43,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Saint-Maurice-l'Exil","38550",{"type":45,"coordinates":127},[128,129],4.78303,45.38514,{"lat":129,"lon":128},[132],{"name":133,"role":31,"phone":134,"phoneExt":24,"email":135},"Claire DAMATTE-FAUCHERY","+33 6 79 89 57 31","claire.damatte-fauchery@orange.fr",{"facility":39,"status":24,"city":137,"state":24,"zip":138,"country":42,"countryCode":43,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Sathonay-Camp","69580",{"type":45,"coordinates":140},[141,142],4.87453,45.82462,{"lat":142,"lon":141},[145],{"name":146,"role":31,"phone":147,"phoneExt":24,"email":148},"Sylvie MARSOT","+33 6 41 67 71 10","sylviemarsot@neuf.fr",{"type":150,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100613763","screening-for-masld-related-advanced-fibrosis-in-type-2-diabetes-100613763",false,"NCT07270822","Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes","Implementation of a Systematic Screening for MASLD-related Advanced fibrosiS for Patients With Type 2 Diabetes folLoweD by DIABetologists","MASLD-DIAB","Inclusion Criteria:\n\n* Adult patient, male or female\n* Type 2 diabetic patient, followed by a diabetologist in private practice participating in the study\n* Patient affiliated to a French or European healthcare insurance\n* Patient who agrees to be included in the study and who signs the informed consent form\n\nExclusion Criteria:\n\n* Evidence of advanced fibrosis (F3 or F4 fibrosis based on the results from previous liver biopsy F3 ou F4 or evidence of cirrhosis).\n* Evidence of other causes of chronic liver disease\n* Patient who does not understand French\u002F is unable to give consent,\n* Patient already included in a trial who may interfere with the study\n* The subject is a pregnant or nursing female\n* Minor patient\n* Patient deprived of liberty,\n* Patient admitted to a health or social establishment for purposes other than research\n* Mentally unbalanced patients, under supervision or guardianship,\n* Patient undergoing psychiatric care\n* Patient not affiliated to a healthcare insurance plan\n* Patient already included in this screening program in the previous 12 months","ALL","18 Years",{"count":162,"type":163},1714,"ESTIMATED","INTERVENTIONAL",[166],"NA","Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately 25% of the global adult population, 25-30% of whom suffer from metabolic dysfunction-associated steatohepatitis (MASH), increasing the risk of progression to advanced fibrosis (AF) (fibrosis stage F3 or cirrhosis F4). Screening for AF is justified because it is associated with an increased risk of overall, hepatic, and cardiovascular mortality and therefore constitutes a public health issue.\n\nPatients with type 2 diabetes (T2D) are identified as a priority target for screening because they are at high risk of AF related to MASLD. The recommendations of the French Association for the Study of the Liver 2020 (afef.asso.fr), the European Association for the Study of the Liver (2024), the American Association of Clinical Endocrinology (2022), and the American Association of Diabetes (2025) all recommend a two-step screening process involving the FIB-4 biological score, followed by transient elastography (TE) if the FIB-4 score is \\> or = 1.30. Finally, if the TE is ≥8 kPa, the patient is considered to be at intermediate\u002Fhigh risk of AF requiring specialized care to confirm the diagnosis and implement appropriate management, including semi-annual screening for hepatocellular carcinoma in cases of cirrhosis Despite these recommendations, their application in clinical practice remains difficult and requires multidisciplinary collaboration between diabetologists and hepatologists, and between community and hospital sectors, particularly to access TE measures.\n\nSince 2018, the Lyon Sud diabetes department (Hospices Civils de Lyon) has implemented an in-hospital AF screening program using TE for T2D patients. However, this screening by private diabetologists has not yet been implemented, mainly due to the lack of a standardized care pathway and difficulty in accessing TE measurements.\n\nHYPOTHESIS The implementation of systematic and standardized AF screening in private diabetes practices, in two stages and using ET in diabetes care in accordance with recommendations, would significantly increase the identification of patients with AF and thus improve their access to specialized services and appropriate care.",[169,170],"Steatotic Liver Disease","Fibrosis of Liver",[172,173,174,175,176,177],"Metabolic dysfunction-associated steatotic liver disease","hepatic transient elastography","hepatic fibrosis","type 2 diabetes mellitus","screening","non-invasive tests","NOT_YET_RECRUITING","2026-04-02",{"date":181,"type":182},"2026-04-03","ACTUAL",{"date":184,"type":163},"2026-05-01",{"date":186,"type":163},"2029-03-01",{"name":5,"class":6},10]