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Completed

NCT Number: NCT02184676

T1D Risk Assessment in Kids With Relatives

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.

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Key information

Age range

1 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochin Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Analysis of early immune modifications

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

Other
  • 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 outcomes

  1. Autoreactive T lymphocytes

    Time frame: 48 months

    presence, frequency, antigen specificity, phenotype

Secondary outcomes

  1. Metagenomic signatures

    Time frame: 48 months

    presence, frequency, type

  2. Metabolic signatures

    Time frame: 48 months

    presence, frequency, type

  3. Environmental factors

    Time frame: 48 months

    • 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
  4. Incidence of autoantibodies

    Time frame: 48 months

    Presence, titer, specificity

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • 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 Recherche pour l'Agriculture, l'Alimentation et l'Environnement
  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: TRAKR

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2014
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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