Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up
- Conditions
- Autoimmune DiseasesType 1 DiabetesHashimoto DiseaseCeliac DiseaseVitiligoGraves DiseaseAddison Disease
- Registration Number
- NCT04789993
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- 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
- type 1 diabetes diagnostic not certain
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type of additional autoimmune diseases at type 1 diabetes diagnosis up to 3 weeks after type 1 diabetes diagnosis Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
Number of additional autoimmune diseases at type 1 diabetes diagnosis up to 3 weeks after type 1 diabetes diagnosis Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
- Secondary Outcome Measures
Name Time Method Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5 From type 1 diabetes diagnosis to last news date, from 1 to 6 years Antibodies 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)
Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetes during follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 years presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases
Occurence of specific treatment onset in patients followed for type 1 diabetes with thyroid dysfunction due to Hashimoto From type 1 diabetes diagnosis to last news date, from 1 to 6 years Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnostic up to 3 weeks after type 1 diabetes diagnosis Family 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 disease From type 1 diabetes diagnosis to last news date, from 1 to 6 years Antibodies 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 dysfunction Up to 3 weeks after type 1 diabetes diagnosis Thyroid dysfunction : hormonal dysfunction associated to Hashimoto
Characteristics of patients, if additional autoimmune disease is present or absent up to 3 weeks after type 1 diabetes diagnosis Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Occurence or non-occurence of at least one additional autoimmune diseases during follow-up From type 1 diabetes diagnostic to last news date, an average of 3 years Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
Occurence or non-occurence of each type of additional autoimmune disease during follow-up From type 1 diabetes diagnostic to last news date, an average of 3 years Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations, in this outcome studied each one separately
Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetes Up to 3 weeks after type 1 diabetes diagnosis Family 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
Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnostic up to 3 weeks after type 1 diabetes diagnosis Antibodies 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 of thyroid dysfunction in patients with type 1 diabetes and Hashimoto From type 1 diabetes diagnosis to last news date, from 1 to 6 years Occurence during type 1 diabetes follow-up of thyroid dysfunction in patients with Hashimoto
Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnostic up to 3 weeks after type 1 diabetes diagnosis Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune disease From type 1 diabetes diagnosis to last news date, from 1 to 6 years Antibodies 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)
Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatment Up to 3 weeks after type 1 diabetes diagnosis
Trial Locations
- Locations (1)
Hôpital d'Enfants de Brabois
🇫🇷Vandoeuvre les nancy, Lorraine, France