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.
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
- Conditions the study is for
- Metabolic Diseases, Diabetes Mellitus (Type 2), Genetic Variation
- How many people
- 118 participants
- Where
- 1 siteGuadeloupe
- Study dates
- Jun 2026to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
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
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.
- Conditions
- Metabolic Diseases, Diabetes Mellitus (Type 2), Genetic Variation, Genetic Profile, Glucose Metabolism Disorders
- 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 group | Role | What they receive |
|---|---|---|
| case | subjects 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.
known pathogenic mutations described in monogenic diabetes of the MODY type
pourcentage
Measured: At inclusion
Secondary outcomes (4)
new pathogenic mutations identified in genes involved in glucose metabolism and its regulation,
pourcentage
Measured: At inclusion
genetic mutations.
présence/absence
Measured: At inclusion
association between clinical and biological data and DNAI
odds ration
Measured: At inclusion
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.
- First posted8 May 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fritz-Line VELAYOUDOM, Doctor, Principal investigator, CHU de la Guadeloupe
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Clinical, Biological and Genetic Specificities of Atypical Non-AutoImmune Diabetes (ANAID) in the French West Indies
- ClinicalTrials.gov ID
- NCT07576374
- Acronym / sponsor ID
- DiAGeNA / PAP_RIPH2_2025/09
- Conditions
- Metabolic Diseases, Diabetes Mellitus (Type 2), Genetic Variation, Genetic Profile, Glucose Metabolism Disorders
- Keywords
- Genetic diagnosis, Monogenic diabetes, Exome sequencing, Pathogenic variant, Ketoacidosis, Afro-Caribbean, African and Indian ancestry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case | – | –subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.
Key inclusion criteria (11 listed)
- Subjects from Indian or African Ancestry self-declared
- 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
- 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
- Anti-islet antibodies (ICA) Anti-IA2 antibodies Anti-insulin antibodies Anti-ZnT8 antibodies Anti-GAD antibodies
- Informed consent signed by the patient
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
known pathogenic mutations described in monogenic diabetes of the MODY type
Time frame: At inclusion
pourcentage
4 secondary outcomes
new pathogenic mutations identified in genes involved in glucose metabolism and its regulation,
Time frame: At inclusion
genetic mutations.
Time frame: At inclusion
association between clinical and biological data and DNAI
Time frame: At inclusion
comparing the genetic data found in African and Indian ancestry population
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fritz-Line VELAYOUDOM, Doctor principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Diseases and Diabetes Mellitus (Type 2), run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fritz-Line VELAYOUDOM, Doctor (0590 89 13 00, fritz-line.velayoudom@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
known pathogenic mutations described in monogenic diabetes of the MODY type (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.