About this trial
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.
Notably, the questions it aims to answer are:
* The feasibility of the WGS coupled with MCM on diagnosis of atypical forms of diabetes, * 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.
After inclusion and sampling for genotyping, patients will be followed for 5 years.
The target population is 1020 adults with atypical diabetes for whom it is possible to obtain a blood sample.
Eligibility criteria
Qualifiers
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/IDF Consultation. Geneva, World Health Org., 2006.)
Age ≤ 45 years at diabetes diagnosis
Body mass index ≤ 35 kg/m² at diabetes diagnosis
Negative results of specific antibodies determination (GAD65, IA2, ZnT8) until the inclusion visit
Disqualifiers
Pregnant or breastfeeding woman,
Any contraindication to the study exams including known allergies or contraindication to contrasts for the scan
Patient with known monogenic diabetes (defined as identification of class 4 and 5 variants according to ACMG)
First or second-degree relatives with monogenic diabetes established by molecular genetics (class 4 and 5 variants according to ACMG)
Trial design
Treatments tested in this trial
- WGS coupled with MCM
Treatment groups
Sponsors and collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Lead sponsor
Commissariat A L'energie Atomique
Collaborator
Rennes University Hospital
Collaborator
Central Hospital, Nancy, France
Collaborator
Nantes University Hospital
Collaborator
Imagine Institute
Collaborator
APHP
Collaborator
Hospices Civils de Lyon
Collaborator
Université Lumière Lyon 2
Collaborator
University Hospital, Toulouse
Collaborator