Type 1 DiabetesTRAKRNCT02184676
T1D Risk Assessment in Kids With Relatives
A study testing Analysis of early immune modifications and Collection of clinical and socio-demographic data in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Analysis of early immune modifications and Collection of clinical and socio-demographic data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2015to 17 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Severe foetal disease
- Severe congenital malformation
- Congenital measles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort
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.
Read the 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
- Being tested
- Analysis of early immune modifications, Collection of clinical and socio-demographic data
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of early immune modificationsBiological
- 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 dataOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Children born to mother/father with type 1 diabetes | Other | Not described Receives: Biological: Analysis of early immune modifications; Other: Collection of clinical and socio-demographic data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoreactive T lymphocytes
presence, frequency, antigen specificity, phenotype
Measured: 48 months
Secondary outcomes (4)
Metagenomic signatures
presence, frequency, type
Measured: 48 months
Metabolic signatures
presence, frequency, type
Measured: 48 months
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
Measured: 48 months
Incidence of autoantibodies
Presence, titer, specificity
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start28 May 2015
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, 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, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Roberto Mallone, M.D, Ph.D., Principal investigator, INSERM U1016
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184676
- Sponsor's protocol ID
- P130405
- Other IDs
- ID RCB : 2014-A00453-44
- Acronym
- TRAKR
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2014
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort
- ClinicalTrials.gov ID
- NCT02184676
- Acronym / sponsor ID
- TRAKR / P130405
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, risk assessment, immunological marker, children, relatives, autoantibodies, lymphocytes, T cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, 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, URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 May 2015 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children born to mother/father with type 1 diabetes | Other | Biological: Analysis of early immune modifications, Other: Collection of clinical and socio-demographic data |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Mother and/or father with type 1 diabetes
- Mother/father without Type 1 diabetes
- Children born to mother and/or father with type 1 diabetes
Key exclusion criteria (9 listed)
- 1) Mother/father
- secondary forms of diabetes
- monogenic forms of diabetes
- 1 or 2) For the mother
- malignant neoplastic or psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Children born to mother/father with type 1 diabetes |
| Collection of clinical and socio-demographic data1. 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 | Other | Children born to mother/father with type 1 diabetes |
Primary outcome
Autoreactive T lymphocytes
Time frame: 48 months
presence, frequency, antigen specificity, phenotype
4 secondary outcomes
Metagenomic signatures
Time frame: 48 months
Metabolic signatures
Time frame: 48 months
Environmental factors
Time frame: 48 months
Incidence of autoantibodies
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Mallone, M.D, Ph.D. principal investigator
INSERM U1016
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of early immune modifications and Collection of clinical and socio-demographic data in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autoreactive T lymphocytes (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.