Analysis of Viral Infections' Exposition Preceding the Type 1 Diabetes (T1D) Diagnostic in Children of the Isis-Diab Cohort. Search for Explanations of of the Disease's Early Onset

NCT02425410 | Unknown

• 1 other identifier: AOM 10061
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate viral factors determining the early onset of T1D. Thanks to the quantification of viral exposures of T1D patients before the disease onset with questionnaires and environmental databases analyses, and through whole genome association studies of these patients, investigators could attempt to identify gene-virus interactions determining the age of T1D onset.

Conditions

Diabetes Mellitus; Insulin-Dependent

Keywords

Diabetes Mellitus; Insulin-Dependent; Virus Diseases; Questionnaires; Risk assessment; Genome-Wide Association Study

Outcome Measures

Primary Outcomes (2)

• Occurrence of viral events before T1D diagnosis

  From birth to 2 years

• Delay between viral events and T1D diagnosis

  From birth to 2 years

Secondary Outcomes (1)

• Age at T1D diagnosis as a quantitative trait

  From birth to 2 years

Study Arms (1)

Isis-Virus

T1D patients of the Isis-Diab cohort with genetic data (GWAS) and specific environmental data on viral events during childhood

Other: Collect of data on viral environment of T1D patients; Genetic: Collect of blood samples for DNA extraction and genetic characterization (GWAS)

Interventions

Collect of data on viral environment of T1D patients OTHER

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

Isis-Virus

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

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

Isis-Virus

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of the Isis-Diab cohort, i.e. T1D patients aged more than 6 months, already sampled for genetic analysis.

You may qualify if:

• Type 1 diabetic patients included in the Isis-Diab cohort
• Patients with available genetic data (GWAS)

You may not qualify if:

• Patient refusal (or parents) to participate in the study.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Centre National de Génotypage: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Inserm U986

Le Kremlin-Bicêtre, 94276, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (already collected for the Isis-Diab project)

MeSH Terms

Conditions

Diabetes Mellitus; Virus Diseases

Interventions

Genome-Wide Association Study

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Molecular Epidemiology; Genetic Association Studies; Genetic Techniques; Oligonucleotide Array Sequence Analysis; Sequence Analysis; Public Health; Environment and Public Health

Study Officials

• Alain-Jacques Valleron, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

• Pierre Bougnères, MD, PhD

  Inserm U986 / Pediatric endocrinology department of the Bicêtre Hospital (AP-HP)

  STUDY DIRECTOR

Central Study Contacts

Sophie Le Fur, PhD

CONTACT

+33 1 49 59 53 43; sophie.le-fur@inserm.fr

Laurence LECOMTE, PhD

CONTACT

+ 33 1 71 19 64 94; laurence.lecomte@nck.aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: April 24, 2015
• Study Start: March 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

FR (1)