Genetic and Environmental Risk Factors of Type 1 Autoimmune Diabetes and Its Early Complications

NCT02212522 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2016-06-28

No results posted yet for this study

Summary

The aim of this study is to complete the identification of genetic factors (G) and to undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G analysis (whole genome genotyping done once a patient using methods conually updated at Centre National de Genotype) and innovative E analysis to develop the following long term objectives :

* Identify G and E factors influencing the process of remaining beta cells' destruction during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years diabetes duration);
* Identify G factors (pharmacogenomics) of the individual response to insulin using the effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients with negative C-peptide and well managed diabetes);
* Undertake a prospective research of G and E risk factors of "death in bed" syndrome in diabetic adolescents;
* Undertake a prospective research of G and E risk factors of incipient glomerular microangiopathy (regule measurement of microalbuminuria).

Conditions

Interventions

OTHER

Collect of environmental data on T1D patients before diagnosis

Questionnaires on large environment during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data

GENETIC

Collect of blood samples for DNA extraction and genetic characterization (GWAS)

Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotype)

OTHER

Collect of clinical data on the disease and its evolution

Collect of clinical data on the disease and its evolution every 6 months after enrollment

OTHER

Collect of environmental data on French controls (age-matched for T1D patients)

Questionnaires on large environment during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data

GENETIC

Collect of blood samples for DNA extraction and genetic characterization (GWAS)

Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotype)

Sponsors & Collaborators

  • Centre National de Génotypage

    collaborator OTHER
  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pierre BOUGNERES, MD-PhD · Inserm U986/ Pediatric endocrinology department of the Bicêtre hospital

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2017-12-31
Completion
2018-06-30

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02212522 on ClinicalTrials.gov