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

Type 1 Diabetes Clinical Trial

— AADT1D  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04789993
• Other study ID #: 2020PI283
• Status: Enrolling by invitation
• Start date: March 15, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: March 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• No 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.

Locations

Country	Name	City	State
France	Hôpital d'Enfants de Brabois	Vandoeuvre les nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of additional autoimmune diseases at type 1 diabetes diagnosis	Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations	up to 3 weeks after type 1 diabetes diagnosis
Primary	Type of additional autoimmune diseases at type 1 diabetes diagnosis	Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations	up to 3 weeks after type 1 diabetes diagnosis
Secondary	Characteristics of patients, if additional autoimmune disease is present or absent	Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic	up to 3 weeks after type 1 diabetes diagnosis
Secondary	Occurence or non-occurence of at least one additional autoimmune diseases during follow-up	Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations	From type 1 diabetes diagnostic to last news date, an average of 3 years
Secondary	Occurence or non-occurence of each type of additional autoimmune disease during follow-up	Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations, in this outcome studied each one separately	From type 1 diabetes diagnostic to last news date, an average of 3 years
Secondary	Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnostic	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)	up to 3 weeks after type 1 diabetes diagnosis
Secondary	Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnostic	Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic	up to 3 weeks after type 1 diabetes diagnosis
Secondary	Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnostic	Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic	up to 3 weeks after type 1 diabetes diagnosis
Secondary	Occurence or non-occurence of at least one type of antibody specific to an additional autoimmune disease	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)	From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Secondary	Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5	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)	From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Secondary	Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetes	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	Up to 3 weeks after type 1 diabetes diagnosis
Secondary	Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetes	presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases	during follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Secondary	If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune disease	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)	From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Secondary	If patient diagnosed with Hashimoto when type 1 diabetes is diagnosed, proportion of patients with thyroid dysfunction	Thyroid dysfunction : hormonal dysfunction associated to Hashimoto	Up to 3 weeks after type 1 diabetes diagnosis
Secondary	Occurence of thyroid dysfunction in patients with type 1 diabetes and Hashimoto	Occurence during type 1 diabetes follow-up of thyroid dysfunction in patients with Hashimoto	From type 1 diabetes diagnosis to last news date, from 1 to 6 years
Secondary	Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatment		Up to 3 weeks after type 1 diabetes diagnosis
Secondary	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