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Institute",{"name":396,"class":388},"APHP",{"name":398,"class":388},"Hospices Civils de Lyon",{"name":400,"class":388},"Université Lumière Lyon 2",{"name":402,"class":388},"University Hospital, Toulouse","100559910","role-of-high-throughput-whole-genome-sequencing-for-the-diagnosis-and-care-of-atypical-diabetes-100559910",false,"NCT06570278","Role of High-Throughput Whole Genome Sequencing for the Diagnosis and Care of Atypical Diabetes","GLUCOGEN","Inclusion Criteria:\n\n* Subjects ≥18 years with confirmed diabetes mellitus according to WHO criteria (World Health Organization: Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: Report of a WHO\u002FIDF Consultation. Geneva, World Health Org., 2006.)\n* Age ≤ 45 years at diabetes diagnosis\n* Body mass index ≤ 35 kg\u002Fm² at diabetes diagnosis\n* Negative results of specific antibodies determination (GAD65, IA2, ZnT8) until the inclusion visit\n* Presenting atypical diabetes defined by at least one of the following:\n* Exocrine pancreatic disease\n* Familial history: diabetes diagnosed in a parent, child or sibling\n* Notion of familial consanguinity\n* Syndromic clinical features (dysmorphy, developmental delay, mental retardation…) or unusual abnormalities\u002Ffeatures that are not part of diabetic complications or co-morbidities;\n* Early occurrence of microvascular complications (≤ 5 years after diabetes diagnosis)\n* Major insulinopenia at diagnosis (C peptide \\\u003C 0.2 nmol\u002FL and\u002For documented ketosis)\n* Patient who conserved endogenous insulin secretion (positive C peptide value) but a need for insulin therapy initiation during the first year following diagnosis due to therapeutic failure of well conducted therapeutic intensification\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Patient with a social security number in compliance with the French law (dispositions relatives aux recherches impliquant la personne humaine prévues aux articles L 1121-1 et suivants du Code de la Santé Publique)\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman,\n* Any contraindication to the study exams including known allergies or contraindication to contrasts for the scan\n* Patient with known monogenic diabetes (defined as identification of class 4 and 5 variants according to ACMG)\n* First or second-degree relatives with monogenic diabetes established by molecular genetics (class 4 and 5 variants according to ACMG)\n* Patient with known secondary diabetes (i.e. endocrine disorders such as Cushing syndrome, pancreatectomy, drug-induced diabetes)\n* Patient who had a bone marrow transplant\n* Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol,\n* Individuals under legal protection (sauvegarde de justice).","ALL","18 Years",{"count":413,"type":414},1020,"ESTIMATED","INTERVENTIONAL",[417],"NA","The main objective of the study is to assess the contribution of whole genome sequencing (WGS) coupled with a multidisciplinary conciliation meeting (MCM) on diagnosis of atypical forms of diabetes compared to an in-silico analysis of a panel of validated genes (ISApanel), corresponding to current practice, in a randomized trial.\n\nNotably, the questions it aims to answer are:\n\n* The feasibility of the WGS coupled with MCM on diagnosis of atypical forms of diabetes,\n* The contribution of WGS coupled with MCM on number of genetic alterations likely causal of diabetes identified and with a modification in care and support of patients.\n\nAfter inclusion and sampling for genotyping, patients will be followed for 5 years.\n\nThe target population is 1020 adults with atypical diabetes for whom it is possible to obtain a blood sample.",[420],"Diabetes Mellitus",[422,423,424],"Next generation sequencing genome","Diagnostic study","Medico-economic study","2026-04-08",{"date":427,"type":428},"2026-04-09","ACTUAL",{"date":430,"type":428},"2024-10-30",{"date":432,"type":414},"2034-11",{"name":5,"class":6},26]