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New treatment option for Diabetes Mellitus
Official title Role of High-Throughput Whole Genome Sequencing for the Diagnosis and Care of Atypical Diabetes
ClinicalTrials.gov ID: NCT06570278
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people ≥18 years with confirmed diabetes mellitus according to WHO criteria (World Health Organization: Definition and diagnosis of diabetes mellitus...
- 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:
You likely can't join if
- 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)
- Patient with known secondary diabetes (i.e. endocrine disorders such as Cushing syndrome, pancreatectomy, drug-induced diabetes)
- Patient who had a bone marrow transplant
See the full eligibility criteria
- people ≥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...
- 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...
- 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
- 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)
- Patient with known secondary diabetes (i.e. endocrine disorders such as Cushing syndrome, pancreatectomy, drug-induced diabetes)
- Patient who had a bone marrow transplant
- 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,
- Individuals under legal protection (sauvegarde de justice).
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Corbeil-Essonnes, France
- Dijon, France
- Grenoble, France
- Le Kremlin-Bicêtre, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Poitiers, France
- Rennes, France
- Rouen, France
- Strasbourg, France
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Besançon, France; Bordeaux, France; Brest, France; Corbeil-Essonnes, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.