Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 3:47 AM
Study NCT ID:
NCT04789993
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2021-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D050031', 'term': 'Hashimoto Disease'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D000224', 'term': 'Addison Disease'}, {'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000309', 'term': 'Adrenal Insufficiency'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2021-02-20', 'studyFirstSubmitQcDate': '2021-03-06', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of additional autoimmune diseases at type 1 diabetes diagnosis', 'timeFrame': 'up to 3 weeks after type 1 diabetes diagnosis', 'description': 'Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations'}, {'measure': 'Type of additional autoimmune diseases at type 1 diabetes diagnosis', 'timeFrame': 'up to 3 weeks after type 1 diabetes diagnosis', 'description': 'Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations'}], 'secondaryOutcomes': [{'measure': 'Characteristics of patients, if additional autoimmune disease is present or absent', 'timeFrame': 'up to 3 weeks after type 1 diabetes diagnosis', 'description': 'Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic'}, {'measure': 'Occurence or non-occurence of at least one additional autoimmune diseases during follow-up', 'timeFrame': 'From type 1 diabetes diagnostic to last news date, an average of 3 years', 'description': 'Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations'}, {'measure': 'Occurence or non-occurence of each type of additional autoimmune disease during follow-up', 'timeFrame': 'From type 1 diabetes diagnostic to last news date, an average of 3 years', 'description': 'Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations, in this outcome studied each one separately'}, {'measure': 'Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnostic', 'timeFrame': 'up to 3 weeks after type 1 diabetes diagnosis', 'description': '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)'}, {'measure': 'Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnostic', 'timeFrame': 'up to 3 weeks after type 1 diabetes diagnosis', 'description': 'Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic'}, {'measure': 'Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnostic', 'timeFrame': 'up to 3 weeks after type 1 diabetes diagnosis', 'description': 'Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic'}, {'measure': 'Occurence or non-occurence of at least one type of antibody specific to an additional autoimmune disease', 'timeFrame': 'From type 1 diabetes diagnosis to last news date, from 1 to 6 years', 'description': '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)'}, {'measure': 'Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5', 'timeFrame': 'From type 1 diabetes diagnosis to last news date, from 1 to 6 years', 'description': '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)'}, {'measure': 'Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetes', 'timeFrame': 'Up to 3 weeks after type 1 diabetes diagnosis', 'description': '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'}, {'measure': 'Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetes', 'timeFrame': 'during follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 years', 'description': 'presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases'}, {'measure': 'If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune disease', 'timeFrame': 'From type 1 diabetes diagnosis to last news date, from 1 to 6 years', 'description': '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)'}, {'measure': 'If patient diagnosed with Hashimoto when type 1 diabetes is diagnosed, proportion of patients with thyroid dysfunction', 'timeFrame': 'Up to 3 weeks after type 1 diabetes diagnosis', 'description': 'Thyroid dysfunction : hormonal dysfunction associated to Hashimoto'}, {'measure': 'Occurence of thyroid dysfunction in patients with type 1 diabetes and Hashimoto', 'timeFrame': 'From type 1 diabetes diagnosis to last news date, from 1 to 6 years', 'description': 'Occurence during type 1 diabetes follow-up of thyroid dysfunction in patients with Hashimoto'}, {'measure': 'Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatment', 'timeFrame': 'Up to 3 weeks after type 1 diabetes diagnosis'}, {'measure': 'Occurence of specific treatment onset in patients followed for type 1 diabetes with thyroid dysfunction due to Hashimoto', 'timeFrame': 'From type 1 diabetes diagnosis to last news date, from 1 to 6 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Autoimmune Diseases', 'Pediatrics', 'Children', 'Adolescents'], 'conditions': ['Type 1 Diabetes', 'Autoimmune Diseases', 'Hashimoto Disease', 'Graves Disease', 'Celiac Disease', 'Addison Disease', 'Vitiligo']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Every patient followed for type 1 diabetes at the Children's Hospital of Nancy, France, between 2014-01-01 and 2021-02-01.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* age \\< 18 years old at type 1 diabetes diagnostic\n* type 1 diabetes diagnosed between 2014-01-01 and 2021-02-01\n\nExclusion Criteria:\n\n* type 1 diabetes diagnostic not certain'}, 'identificationModule': {'nctId': 'NCT04789993', 'acronym': 'AADT1D', 'briefTitle': 'Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Additional Autoimmune Diseases With Type 1 Diabetes in Children and Adolescents at Diabetes Diagnostic and During Follow-up : a Monocentric Study in France', 'orgStudyIdInfo': {'id': '2020PI283'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention.', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': "Hôpital d'Enfants de Brabois", 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Carole LEGAGNEUR, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Centre Hospitalo-Universitaire de Nancy, Hôpital d'Enfants de Brabois"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'LEGAGNEUR Carole', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}