T1D Risk Assessment in Kids With Relatives

NCT ID: NCT02184676

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-28
• Study Completion Date: 2019-05-17

Brief 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.

Detailed Description

The prevalence of type 1 diabetes (T1D) is estimated between 0.2 and 0.4% in France. The incidence in France is more than 10/105 per year, with a steady increase (~4%/year), especially in children. Infants born to parents with T1D have a 15-fold higher risk to develop T1D compared to the general population. The appearance of autoantibodies precedes and is highly predictive of the later occurrence of T1D. The activation of B lymphocytes, which produce autoantibodies, is controlled by T helper lymphocytes. Hence, biomarkers associated with initial T lymphocyte activation are likely to precede the appearance of autoantibodies.

The aim of the TRAKR study is to determine whether the appearance of autoreactive T lymphocytes is predictive of the emergence of autoantibodies.

The secondary objectives are: 1) to evaluate whether metagenomic, metabolic, or environmental factors are associated with the appearance of autoantibodies; 2) to evaluate the incidence and the time of autoantibody appearance in a French population of genetically at-risk children; 3) to compare the incidence of autoantibodies between infants born to T1D fathers and mothers.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Children born to mother/father with type 1 diabetes

Group Type: OTHER

Analysis of early immune modifications

Intervention Type: BIOLOGICAL

• 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

Collection of clinical and socio-demographic data

Intervention Type: OTHER

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

Interventions

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

Intervention Type: BIOLOGICAL

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Mother and/or father with type 1 diabetes

• age > 18 years
• type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
• planning to give birth or having given birth since less than 8 months
• agreeing to participate upon written informed consent
• covered by the French social security system

2. Mother/father without Type 1 diabetes

• age > 18 years old
• with a spouse with type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
• planning to give birth or having given birth since less than 8 months
• agreeing to participate upon written informed consent
• covered by the French social security system

3. Children born to mother and/or father with type 1 diabetes

• age < 8 months
• with at least one parent with T1D
• with both parents agreeing to participate
• both parents covered by the French social security system

Exclusion Criteria

1) Mother/father

• secondary forms of diabetes
• monogenic forms of diabetes

1 or 2) For the mother

• malignant neoplastic or psychiatric disease

3 ) Newborns of mother/father with type 1 diabetes

• Severe foetal disease
• Severe congenital malformation
• Congenital measles

• Minimum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Mallone, M.D, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

INSERM U1016

Locations

Cochin Hospital

Paris, , France

Countries

France

Other Identifiers

ID RCB : 2014-A00453-44

Identifier Type: -

Identifier Source: secondary_id

P130405

Identifier Type: -

Identifier Source: org_study_id