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Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up

Additional Autoimmune Diseases With Type 1 Diabetes in Children and Adolescents at Diabetes Diagnostic and During Follow-up : a Monocentric Study in France

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04789993
Acronym
AADT1D
Enrollment
250
Registered
2021-03-10
Start date
2021-03-15
Completion date
2021-04-30
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addison Disease, Autoimmune Diseases, Celiac Disease, Graves Disease, Hashimoto Disease, Type 1 Diabetes, Vitiligo

Keywords

Type 1 diabetes, Autoimmune Diseases, Pediatrics, Children, Adolescents

Brief summary

This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France's centers of reference for paediatric diabetes.

Interventions

OTHERNo intervention.

There is no intervention needed. It is a retrospective cohort. The usual follow-up of type 1 diabetes is studied from its beginning to the last news of the patient.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with type 1 diabetes diagnosed with the following criteria: (i) Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dl), or (ii) fasting plasma glucose ≥7.0 mmol/l (≥126 mg/dl) ; and (iii) presence of diabetes associated autoantibodies : ICA, GAD, IA2, IAA and/or ZnT8 * age \< 18 years old at type 1 diabetes diagnostic * type 1 diabetes diagnosed between 2014-01-01 and 2021-02-01

Exclusion criteria

* type 1 diabetes diagnostic not certain

Design outcomes

Primary

MeasureTime frameDescription
Number of additional autoimmune diseases at type 1 diabetes diagnosisup to 3 weeks after type 1 diabetes diagnosisWill be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
Type of additional autoimmune diseases at type 1 diabetes diagnosisup to 3 weeks after type 1 diabetes diagnosisWill be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations

Secondary

MeasureTime frameDescription
Occurence or non-occurence of each type of additional autoimmune disease during follow-upFrom type 1 diabetes diagnostic to last news date, an average of 3 yearsWill be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations, in this outcome studied each one separately
Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnosticup to 3 weeks after type 1 diabetes diagnosisAntibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnosticup to 3 weeks after type 1 diabetes diagnosisFamily and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnosticup to 3 weeks after type 1 diabetes diagnosisFamily and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Occurence or non-occurence of at least one type of antibody specific to an additional autoimmune diseaseFrom type 1 diabetes diagnosis to last news date, from 1 to 6 yearsAntibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5From type 1 diabetes diagnosis to last news date, from 1 to 6 yearsAntibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
Characteristics of patients, if additional autoimmune disease is present or absentup to 3 weeks after type 1 diabetes diagnosisFamily and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetesduring follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 yearspresence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases
If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune diseaseFrom type 1 diabetes diagnosis to last news date, from 1 to 6 yearsAntibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
If patient diagnosed with Hashimoto when type 1 diabetes is diagnosed, proportion of patients with thyroid dysfunctionUp to 3 weeks after type 1 diabetes diagnosisThyroid dysfunction : hormonal dysfunction associated to Hashimoto
Occurence of thyroid dysfunction in patients with type 1 diabetes and HashimotoFrom type 1 diabetes diagnosis to last news date, from 1 to 6 yearsOccurence during type 1 diabetes follow-up of thyroid dysfunction in patients with Hashimoto
Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatmentUp to 3 weeks after type 1 diabetes diagnosis
Occurence of specific treatment onset in patients followed for type 1 diabetes with thyroid dysfunction due to HashimotoFrom type 1 diabetes diagnosis to last news date, from 1 to 6 years
Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetesUp to 3 weeks after type 1 diabetes diagnosisFamily and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic, presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases
Occurence or non-occurence of at least one additional autoimmune diseases during follow-upFrom type 1 diabetes diagnostic to last news date, an average of 3 yearsWill be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026