Actively Recruiting
Role of High-Throughput Whole Genome Sequencing for the Diagnosis and Care of Atypical Diabetes
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-04-09
1020
Participants Needed
26
Research Sites
522 weeks
Total Duration
On this page
Sponsors
I
Institut National de la Santé Et de la Recherche Médicale, France
Lead Sponsor
C
Commissariat A L'energie Atomique
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of High-Throughput Whole Genome Sequencing for the Diagnosis and Care of Atypical Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with confirmed diabetes mellitus according to WHO criteria
- Diabetes diagnosis at age 45 years or younger
- Body mass index of 35 kg/m² or less at diabetes diagnosis
- Negative results for specific antibodies (GAD65, IA2, ZnT8) before inclusion
- Presence of atypical diabetes defined by at least one of the following: exocrine pancreatic disease, family history of diabetes in parent, child or sibling, familial consanguinity, syndromic features (dysmorphy, developmental delay, mental retardation), early microvascular complications within 5 years of diagnosis, major insulin deficiency at diagnosis (C peptide < 0.2 nmol/L or documented ketosis), or need for insulin therapy within the first year after diagnosis due to treatment failure despite preserved insulin secretion
- Willingness to comply with all study procedures and availability for the study duration
- Possession of a social security number in compliance with French law
- Signed and dated informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Any contraindication to study exams, including allergies or contraindication to contrast used in scans
- Known monogenic diabetes diagnosed by molecular genetics (class 4 and 5 variants)
- First or second-degree relatives with established monogenic diabetes by molecular genetics
- Known secondary diabetes due to endocrine disorders, pancreatectomy, or drug-induced causes
- History of bone marrow transplant
- Any condition judged by the investigator to make participation undesirable or likely to affect protocol compliance
- Individuals under legal protection (sauvegarde de justice)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
University Hospital
Amiens, France
Actively Recruiting
2
University Hospital
Angers, France
Actively Recruiting
3
University Hospital Jean Minjoz
Besançon, France
Actively Recruiting
4
University Hospital Haut Lévêque
Bordeaux, France
Actively Recruiting
5
University Hospital Cavale Blanche
Brest, France
Actively Recruiting
6
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Actively Recruiting
7
University Hospital Bocage
Dijon, France
Actively Recruiting
8
University Hospital Michallon
Grenoble, France
Actively Recruiting
9
Assistance Publique Hôpitaux de Paris, Bicêtre Hospital
Le Kremlin-Bicêtre, France
Not Yet Recruiting
10
University Hospital Louis Pradel
Lyon, France
Actively Recruiting
11
University Hospital Sud
Lyon, France
Actively Recruiting
12
University Hospital Conception
Marseille, France
Actively Recruiting
13
University Hospital Lapeyronie
Montpellier, France
Actively Recruiting
14
University Hospital
Nancy, France
Not Yet Recruiting
15
University Hospital Laennec
Nantes, France
Actively Recruiting
16
University Hospital L'Archet
Nice, France
Not Yet Recruiting
17
Assistance Publique Hôpitaux de Paris, Bichat - Claude Bernard Hospital
Paris, France
Actively Recruiting
18
Assistance Publique Hôpitaux de Paris, Cochin Hospital
Paris, France
Actively Recruiting
19
Assistance Publique Hôpitaux de Paris, Lariboisière Hospital
Paris, France
Actively Recruiting
20
Assistance Publique Hôpitaux de Paris, Saint Antoine Hospital
Paris, France
Actively Recruiting
21
Assistance Publique Hôpitaux de Paris- La Pitié Salpêtrière Hospital
Paris, France
Actively Recruiting
22
University Hospital
Poitiers, France
Not Yet Recruiting
23
Rennes University Hospital
Rennes, France
Actively Recruiting
24
University Hospital Bois Guillaume
Rouen, France
Actively Recruiting
25
Strasbourg University Hospital
Strasbourg, France
Actively Recruiting
26
University Hospital Rangueil
Toulouse, France
Actively Recruiting
Research Team
J
Jean-François Gautier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here