T1D Risk Assessment in Kids With Relatives

Summary

The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born from type 1 diabetic parents.

Conditions

• Type 1 Diabetes

Interventions

BIOLOGICAL

Analysis of early immune modifications

* blood and stool sampling in parents during pregnancy (at enrollment, i.e. 7th-8th month of pregnancy) * cord blood sampling * stool sampling in mothers and newborns at birth (day 7) * blood and stool sampling in children at the age of 8, 18, 30 and 42 months

OTHER

Collection of clinical and socio-demographic data

1. Questionnaire filled in by clinicians at enrollment and at birth 2. Self-administered questionnaire filled by parents at enrollment, at birth, and then at month 8, 18, 30 and 42

Sponsors & Collaborators

• Institut National de la Santé et de la Recherche Médicale (INSERM) U1016 - Institut Cochin, Immunology of Diabetes Team, Paris, France

  collaborator UNKNOWN

• INSERM U1153, Epidemiology Research Unit on Perinatal Health and Women and Children Health, Port-Royal Hospital, Paris, France

  collaborator UNKNOWN

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

  collaborator OTHER

• Commissariat A L'energie Atomique

  collaborator OTHER_GOV

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Roberto Mallone, M.D, Ph.D. · INSERM U1016

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Day

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-28

Primary Completion

2019-05-17

Completion

2019-05-17

Countries

• France

Study Locations