Type 2 Diabetes (T2D) Clinical Trials

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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Presenting atypical diabetes defined by at least one of the following:

• Exocrine pancreatic disease

• Familial history: diabetes diagnosed in a parent, child or sibling

• Notion of familial consanguinity

• Syndromic clinical features (dysmorphy, developmental delay, mental retardation…) or unusual abnormalities/features that are not part of diabetic complications or co-morbidities;

• Early occurrence of microvascular complications (≤ 5 years after diabetes diagnosis)

• Major insulinopenia at diagnosis (C peptide \< 0.2 nmol/L and/or documented ketosis)

• 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

• Stated willingness to comply with all study procedures and availability for the duration of the study

• 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)

• Signed and dated informed consent form

Locations
Other Locations
France
University Hospital
RECRUITING
Amiens
University Hospital
RECRUITING
Angers
University Hospital Jean Minjoz
RECRUITING
Besançon
University Hospital Haut Lévêque
RECRUITING
Bordeaux
University Hospital Cavale Blanche
RECRUITING
Brest
Centre Hospitalier Sud Francilien
RECRUITING
Corbeil-essonnes
University Hospital Bocage
RECRUITING
Dijon
University Hospital Michallon
RECRUITING
Grenoble
Assistance Publique Hôpitaux de Paris, Bicêtre Hospital
NOT_YET_RECRUITING
Le Kremlin-bicêtre
University Hospital Louis Pradel
RECRUITING
Lyon
University Hospital Sud
RECRUITING
Lyon
University Hospital Conception
RECRUITING
Marseille
University Hospital Lapeyronie
RECRUITING
Montpellier
University Hospital
NOT_YET_RECRUITING
Nancy
University Hospital Laennec
RECRUITING
Nantes
University Hospital L'Archet
NOT_YET_RECRUITING
Nice
Assistance Publique Hôpitaux de Paris- La Pitié Salpêtrière Hospital
RECRUITING
Paris
Assistance Publique Hôpitaux de Paris, Bichat - Claude Bernard Hospital
RECRUITING
Paris
Assistance Publique Hôpitaux de Paris, Cochin Hospital
RECRUITING
Paris
Assistance Publique Hôpitaux de Paris, Lariboisière Hospital
RECRUITING
Paris
Assistance Publique Hôpitaux de Paris, Saint Antoine Hospital
RECRUITING
Paris
University Hospital
NOT_YET_RECRUITING
Poitiers
Rennes University Hospital
RECRUITING
Rennes
University Hospital Bois Guillaume
RECRUITING
Rouen
Strasbourg University Hospital
RECRUITING
Strasbourg
University Hospital Rangueil
RECRUITING
Toulouse
Contact Information
Primary
Jean-François Gautier
jean-francois.gautier@aphp.fr
+33 01 49 95 90 20
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2034-11
Participants
Target number of participants: 1020
Treatments
No_intervention: control procedure
In-silico analysis of a panel of validated genes (ISApanel). Patients recruited along control procedure will stay in their arm using current genetic diagnosis practices and standard of care that may differ from one center to another
Experimental: intervention procedure
WGS coupled with MCM
Related Therapeutic Areas
Sponsors
Collaborators: APHP, Hospices Civils de Lyon, University Hospital, Toulouse, Central Hospital, Nancy, France, Université Lumière Lyon 2, Commissariat A L'energie Atomique, Rennes University Hospital, Nantes University Hospital, Imagine Institute
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov