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T1D Risk Assessment in Kids With Relatives (TRAKR)

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ClinicalTrials.gov Identifier: NCT02184676
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : March 2, 2018
Sponsor:
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 la Recherche Agronomique
Commissariat A L'energie Atomique
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Biological: Analysis of early immune modifications Other: Collection of clinical and socio-demographic data Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort
Actual Study Start Date : May 28, 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Children born to mother/father with type 1 diabetes 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




Primary Outcome Measures :
  1. Autoreactive T lymphocytes [ Time Frame: 48 months ]
    presence, frequency, antigen specificity, phenotype


Secondary Outcome Measures :
  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 ]
    1. Sociodemographic characteristics, e.g. age, gender, occupation, living place, family situation, number of children, education, housing type, animal contact
    2. Family history, e.g. autoimmune diseases
    3. Personal history, e.g. diabetes characteristics, associated co-morbidities, obstetrical history
    4. Clinical data

  4. Incidence of autoantibodies [ Time Frame: 48 months ]
    Presence, titer, specificity



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184676


Contacts
Contact: Christian Boitard, MD PhD + 33 1 58 41 22 40 christian.boitard@cch.aphp.fr
Contact: Nelly Briand +33 1 44 38 18 62 nelly.briand@aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75014
Contact: Roberto Mallone, MD PhD    + 33 1 76 53 55 83    roberto.mallone@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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 la Recherche Agronomique
Commissariat A L'energie Atomique
Investigators
Principal Investigator: Roberto Mallone, M.D, Ph.D. INSERM U1016

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02184676     History of Changes
Other Study ID Numbers: P130405
ID RCB : 2014-A00453-44
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases