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Metabolic DiseasesDiAGeNANCT07576374

Specificities of Atypical Non AutoImmune Diabetes (ANAID) in the French West Indies

An observational study of Metabolic Diseases and Diabetes Mellitus (Type 2), run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Genetics variants could be involved in atypical non-autoimmune diabetes revealed by ketoacidosis. The objective of this research will be to determine the relationships between the genetic variants already described in known monogenic diabetes or identified as involved in glucose metabolism and its regulation, in… Read more about this study

Who is it for?
Ages 18 to 47 years
How many people
118 participants
Where
1 siteGuadeloupe
Study dates
Jun 2026to Sep 2029
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 47 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.

Who may be able to join

  • Phenotypic criteria :
  • Subjects from Indian or African Ancestry self-declared
  • Age criteria at diagnosis:
  • Early onset of diabetes: patient aged between 18 and 47 years at the time of diagnosis of diabetes Clinical criteria: at least 2 criteria Labeled type 2 diabetic
  • Patient hospitalized for:
  • Ketoacid decompensation Significant weight loss (more than 10% in less than 6 months) without obvious etiology Lipodystrophic / lipoatrophic appearance Presence of an associated myopathy or deafness Presence of early inaugural nephropathy or within 3 years after diagnosis Presence of early inaugural heart disease or within 3 years after diagnosis Poor response to non-insulin treatments despite good adherence
Show all 11Show fewer
  • Biological criteria:
  • Absent T1D autoantibodies:
  • Anti-islet antibodies (ICA) Anti-IA2 antibodies Anti-insulin antibodies Anti-ZnT8 antibodies Anti-GAD antibodies
  • Other criteria:
  • Informed consent signed by the patient

Who cannot join

  • Type 1 diabetes (T1D) Presence of T1D antibodies Secondary diabetes (pancreas diseases, endocrine diseases, drug intake, infection) Other associated autoimmune pathologies Pregnancy Refusal to participate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fritz-Line VELAYOUDOM, Doctor contact

0590 89 13 00

fritz-line.velayoudom@chu-guadeloupe.fr

Guadeloupe1 site
  • Centre Hospitalier Universitaire de la Guadeloupe

    Les Abymes, Guadeloupe, 97159

    Fritz-Line VELAYOUDOM, Doctor, 0590934686, fritz-line@chu-guadeloupe.fr

    Eunice NUBRET, 0590934686, eunice.nubret@chu-guadeloupe.fr

Other trials in Guadeloupe

About this study

Official title: Epidemiological, Clinical, Biological and Genetic Specificities of Atypical Non-AutoImmune Diabetes (ANAID) in the French West Indies

Genetics variants could be involved in atypical non-autoimmune diabetes revealed by ketoacidosis. The objective of this research will be to determine the relationships between the genetic variants already described in known monogenic diabetes or identified as involved in glucose metabolism and its regulation, in insulin signaling pathways or in insulin secretion itself in subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.

Read the detailed description

In the French West Indies, the prevalence of diabetes is twice as high as that reported at the national level with a clinical and biological phenotype which seems different, undoubtedly linked to genetic polymorphisms sometimes correlated with specific environmental exposures in these territories. The two most common forms of diabetes are type 1 diabetes (T1D), which accounts for around 5 - 10% of all diabetes, and type 2 diabetes (T2D), which is much more common (around 90 - 95 %). However, in practice, forms of atypical diabetes are described more and more frequently in young subjects, without an autoimmune context, occurring in a family context or not, without the classic phenotype of common type 2 diabetes with the observation in certain populations episodes of ketoacidosis which can be life-threatening. Genetic variants involved in glucose metabolism and its regulation, in insulin signaling pathways, or insulin secretion itself could explain the occurrence of this type of diabetes or episodes of ketoacidosis in these subjects with an evolution towards more or less early insulin withdrawal. The genetic sampling, which is part of the routine etiological diagnosis of these atypical forms, will be carried out with clinical and metabolic evaluation carried out as part of routine care. Unfortunately, this genetic research is not always done systematically. This is a multicenter prospective observational study. This research will be cross-sectional in order to identify in subjects presenting forms of atypical non-autoimmune diabetes (DNAI) found in subjects of African and Indian ancestry in the French West Indies, the presence of known pathogenic mutations described in monogenic diabetes of the MODY type (GCK, HNF1A, HNF4A, PDX1, HNF1B, NEUROD1, CEL, INS, ABCC8, KCNJ11, GATA6, WFS1, TRMT10A, PCBD1, GATA4, APPL1, RFX6, MAFA, SLC19A2, ONECUT1, m.3243A>G, KCNK16) but also new mutations in genes involved in glucose metabolism and its regulation, in insulin signaling pathways, or insulin secretion and this thanks to a molecular screening of the entire exome. A longitudinal follow-up is secondarily planned in order to determine the appearance of complications according to the presence of pathogenic genetic mutations that will have been identified.

Keywords
Genetic diagnosis, Monogenic diabetes, Exome sequencing, Pathogenic variant, Ketoacidosis, Afro-Caribbean, African and Indian ancestry
Medical subject headings
Metabolic Diseases, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Ketosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07576374
Study groupRoleWhat they receive
casesubjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. known pathogenic mutations described in monogenic diabetes of the MODY type

    pourcentage

    Measured: At inclusion

Secondary outcomes (4)
  1. new pathogenic mutations identified in genes involved in glucose metabolism and its regulation,

    pourcentage

    Measured: At inclusion

  2. genetic mutations.

    présence/absence

    Measured: At inclusion

  3. association between clinical and biological data and DNAI

    odds ration

    Measured: At inclusion

  4. comparing the genetic data found in African and Indian ancestry population

    Results with a significant p-value (p < 0.05)

    Measured: At inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07576374
Sponsor's protocol ID
PAP_RIPH2_2025/09
Acronym
DiAGeNA
Status last verified
May 2026
First submitted
4 May 2026
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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