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T1D Risk Assessment in Kids With Relatives (TRAKR)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Analysis of early immune modifications
Collection of clinical and socio-demographic data
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Type 1 Diabetes focused on measuring Type 1 diabetes, risk assessment, immunological marker, children, relatives, autoantibodies, lymphocytes, T cells, epitopes, Children born to mother/father with type 1 diabetes and their parents

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Children born to mother/father with type 1 diabetes

Arm Description

Outcomes

Primary Outcome Measures

Autoreactive T lymphocytes
presence, frequency, antigen specificity, phenotype

Secondary Outcome Measures

Metagenomic signatures
presence, frequency, type
Metabolic signatures
presence, frequency, type
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
Incidence of autoantibodies
Presence, titer, specificity

Full Information

First Posted
July 3, 2014
Last Updated
April 2, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé et de la Recherche Médicale (INSERM) U1016 - Institut Cochin, Immunology of Diabetes Team, Paris, France, INSERM U1153, Epidemiology Research Unit on Perinatal Health and Women and Children Health, Port-Royal Hospital, Paris, France, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Commissariat A L'energie Atomique
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1. Study Identification

Unique Protocol Identification Number
NCT02184676
Brief Title
T1D Risk Assessment in Kids With Relatives
Acronym
TRAKR
Official Title
Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2015 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé et de la Recherche Médicale (INSERM) U1016 - Institut Cochin, Immunology of Diabetes Team, Paris, France, INSERM U1153, Epidemiology Research Unit on Perinatal Health and Women and Children Health, Port-Royal Hospital, Paris, France, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Commissariat A L'energie Atomique

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, risk assessment, immunological marker, children, relatives, autoantibodies, lymphocytes, T cells, epitopes, Children born to mother/father with type 1 diabetes and their parents

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children born to mother/father with type 1 diabetes
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Analysis of early immune modifications
Intervention Description
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
Other
Intervention Name(s)
Collection of clinical and socio-demographic data
Intervention Description
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
Primary Outcome Measure Information:
Title
Autoreactive T lymphocytes
Description
presence, frequency, antigen specificity, phenotype
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Metagenomic signatures
Description
presence, frequency, type
Time Frame
48 months
Title
Metabolic signatures
Description
presence, frequency, type
Time Frame
48 months
Title
Environmental factors
Description
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
Time Frame
48 months
Title
Incidence of autoantibodies
Description
Presence, titer, specificity
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Mallone, M.D, Ph.D.
Organizational Affiliation
INSERM U1016
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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T1D Risk Assessment in Kids With Relatives

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