NCT07576374

Brief 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 insulin signaling pathways or in insulin secretion itself in subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
40mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3.3 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Genetic diagnosisMonogenic diabetesExome sequencingPathogenic variantKetoacidosisAfro-CaribbeanAfrican and Indian ancestry

Outcome Measures

Primary Outcomes (1)

  • known pathogenic mutations described in monogenic diabetes of the MODY type

    pourcentage

    At inclusion

Secondary Outcomes (4)

  • new pathogenic mutations identified in genes involved in glucose metabolism and its regulation,

    At inclusion

  • genetic mutations.

    At inclusion

  • association between clinical and biological data and DNAI

    At inclusion

  • comparing the genetic data found in African and Indian ancestry population

    At inclusion

Study Arms (1)

case

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

Eligibility Criteria

Age18 Years - 47 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de la Guadeloupe

Les Abymes, Guadeloupe, 97159, Guadeloupe

Location

Biospecimen

Retention: SAMPLES WITH DNA

urinairy samples

MeSH Terms

Conditions

Metabolic DiseasesDiabetes Mellitus, Type 2Glucose Metabolism DisordersKetosis

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesAcidosisAcid-Base Imbalance

Study Officials

  • Fritz-Line VELAYOUDOM, Doctor

    CHU de la Guadeloupe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fritz-Line VELAYOUDOM, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations