T1D Risk Assessment in Kids With Relatives

Type 1 Diabetes Clinical Trial

— TRAKR  

Official title:

Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184676
• Other study ID #: P130405
• Secondary ID: ID RCB : 2014-A0
• Status: Completed
• Phase: N/A
• Start date: May 28, 2015
• Est. completion date: May 17, 2019

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (5)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Commissariat A L'energie Atomique, INSERM U1153, Epidemiology Research Unit on Perinatal Health and Women and Children Health, Port-Royal Hospital, Paris, France, Institut National de la Recherche Agronomique, Institut National de la Santé et de la Recherche Médicale (INSERM) U1016 - Institut Cochin, Immunology of Diabetes Team, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autoreactive T lymphocytes	presence, frequency, antigen specificity, phenotype	48 months
Secondary	Metagenomic signatures	presence, frequency, type	48 months
Secondary	Metabolic signatures	presence, frequency, type	48 months
Secondary	Environmental factors	Sociodemographic characteristics, e.g. age, gender, occupation, living place, family situation, number of children, education, housing type, animal contact; Family history, e.g. autoimmune diseases; Personal history, e.g. diabetes characteristics, associated co-morbidities, obstetrical history; Clinical data	48 months
Secondary	Incidence of autoantibodies	Presence, titer, specificity	48 months