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Role of High-Throughput Whole Genome Sequencing for the Diagnosis and Care of Atypical Diabetes

Study acronym: GLUCOGEN
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site details revised at 5 of 26 sites
    • Eligibility criteria expanded, about 5 words
    v5
  2. Site details revised at 16 of 26 sitesv4
  3. Collaborators: 5 to 9v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Oct 30, 2024
    • Site details revised at 26 of 26 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06570278
Lead Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Commissariat A L'energie Atomique, Rennes University Hospital, Central Hospital, Nancy, France, Nantes University Hospital, Imagine Institute, APHP, Hospices Civils de Lyon, Université Lumière Lyon 2, University Hospital, Toulouse
Conditions
(from sponsor)		 Diabetes Mellitus
Related terms Diabetes Mellitus, Disease
Enrollment 1,020 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov