Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
Study NCT ID:
NCT03316261
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2017-10-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Freder1k-Study - Testing Infants for Type 1 Diabetes Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes', 'timeFrame': 'one-time testing before age 6 weeks', 'description': 'increased risk will be identified by risk scores derived from SNPs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infants', 'type 1 diabetes', 'Freder1k'], 'conditions': ['Identification of Infants at Risk for Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '33163984', 'type': 'DERIVED', 'citation': 'Hippich M, Holthaus L, Assfalg R, Zapardiel-Gonzalo J, Kapfelsperger H, Heigermoser M, Haupt F, Ewald DA, Welzhofer TC, Marcus BA, Heck S, Koelln A, Stock J, Voss F, Secchi M, Piemonti L, de la Rosa K, Protzer U, Boehmer M, Achenbach P, Lampasona V, Bonifacio E, Ziegler AG. A Public Health Antibody Screening Indicates a 6-Fold Higher SARS-CoV-2 Exposure Rate than Reported Cases in Children. Med. 2021 Feb 12;2(2):149-163.e4. doi: 10.1016/j.medj.2020.10.003. Epub 2020 Oct 29.'}], 'seeAlsoLinks': [{'url': 'http://www.gppad.org', 'label': 'GPPAD'}]}, 'descriptionModule': {'briefSummary': 'The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.', 'detailedDescription': 'Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. Type 1 diabetes is diagnosed by hyperglycemia often in combination with symptoms of weight loss, thirst, fatigue and frequent urination, sometimes with ketoacidosis. The clinical onset is preceded by an asymptomatic phase identified by serum multiple beta-cell autoantibodies. Neonates and infants who are at increased risk to develop multiple beta-cell autoantibodies and type 1 diabetes can now be identified using genetic markers. This provides opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: up to age 6 weeks\n* provided written informed consent by custodial parent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03316261', 'briefTitle': 'Freder1k-Study - Testing Infants for Type 1 Diabetes Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helmholtz Zentrum München'}, 'officialTitle': 'Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials', 'orgStudyIdInfo': {'id': 'GPPAD-02'}}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anette-G. Ziegler, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Institut für Diabetesforschung, Helmholtz Zentrum München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Anette-Gabriele Ziegler', 'role': 'CONTACT', 'email': 'contact@gppad.org', 'phone': '0800-000 0018'}, {'name': 'Christiane Winkler', 'role': 'CONTACT', 'email': 'contact@gppad.org', 'phone': '0049-89-31873745'}], 'overallOfficials': [{'name': 'Anette-Gabriele Ziegler', 'role': 'STUDY_CHAIR', 'affiliation': 'Helmholtz Zentrum München, IDF-1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helmholtz Zentrum München', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director - Institute of Diabetes Research', 'investigatorFullName': 'Anette-Gabriele Ziegler', 'investigatorAffiliation': 'Helmholtz Zentrum München'}}}}