Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-01-29 @ 11:50 AM
Study NCT ID:
NCT03648918
Status:
RECRUITING
Last Update Posted:
2025-04-28
First Post:
2018-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetics Of Autoimmunity In Type I Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The investigators will be collecting blood samples, which will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, and complete blood count with differential, as well as plasma for storage. Blood will be analyzed for A1c for participants with diabetes. Specimens will be used and stored until none is left.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2001-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2050-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of Type 1 diabetes', 'timeFrame': 'Up to 10 years', 'description': 'The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on the presence of symptoms and unequivocal hyperglycemia.'}, {'measure': 'Autoantibody Measurement', 'timeFrame': 'Up to 10 years', 'description': 'Presence or absence of the autoantibodies related to type 1 diabetes: IA-2 (islet antigen), GAD65 (pancreatic islet cell autoantibody), IAA (insulin autoantibody), ZnT8 (zinc transporter 8)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Family', 'Healthy Controls', 'Siblings'], 'conditions': ['Type1diabetes', 'Diabetes Mellitus, Type 1', 'Type1 Diabetes Mellitus', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.", 'detailedDescription': 'The goal of this project is to gain knowledge about the development of Type 1 diabetes (T1D), as T1D is one of the most common chronic diseases in children. There has been a rise in the number of cases diagnosed as well as a decrease in the age of diagnosis. This project aims to understand the disease progression as seen in the immune system and to define the genetic and environmental factors that affect inflammation and regulation, which could determine disease progression or nonprogression. Families that include a family member with T1D will be recruited, as well as unrelated, healthy controls as a comparison group.\n\nParticipants will have height and weight measured, complete a social \\& medical history questionnaire, and have blood drawn for analysis for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility)diabetes, blood glucose, immune system response, complete blood count, and autoantibody measurements. Some family members may return for follow-up visits for up to 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with T1D seen at clinics at the Children's Wisconsin (n\\~1500) and Froedtert Hospital (n\\~800) will be targeted. In families with a child proband, siblings will be asked to join the study. If the diabetic child has an aunt, uncle, or cousin with T1D, then siblings in that nuclear family will also be recruited. Adult proband families will include the adult affected by T1D and their children. Adult proband families must include children \\<17 years of age. If the adult proband has a sibling, niece, or nephew with T1D, siblings in that nuclear family will be recruited as well. The age-of-diagnosis criterion for the proband will be less than 39 years and insulin therapy started within 5 years of diagnosis.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Families):\n\n* Families where at least one first-degree family member has type 1 diabetes\n* The diabetic proband in the family was diagnosed before the age of 39\n* Family members must be at least 2 years old to participate\n\nExclusion Criteria (Families):\n\n* Families with no history of type 1 diabetes\n* Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)\n\nInclusion Criteria (Controls):\n\n* No family history of type 1 diabetes or other autoimmune conditions\n* Age 2 or older\n\nExclusion Criteria (Controls):\n\n* Personal or family history of autoimmune disease'}, 'identificationModule': {'nctId': 'NCT03648918', 'briefTitle': 'Genetics Of Autoimmunity In Type I Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Genetics Of Autoimmunity In Type I Diabetes', 'orgStudyIdInfo': {'id': '142618'}, 'secondaryIdInfos': [{'id': 'McGee Sibling Study', 'type': 'OTHER', 'domain': 'Medical College of Wisconsin'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood Collection', 'type': 'OTHER', 'description': 'Blood will be collected via venipuncture and analyzed. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, complete blood count with differential, and serum and plasma for storage. For family members with diabetes, blood will also be tested for A1c.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Martin Hessner, PhD', 'role': 'CONTACT', 'email': 't1dinfo@mcw.edu', 'phone': '414-955-4903'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Martin Hessner, PhD', 'role': 'CONTACT', 'email': 't1dinfo@mcw.edu', 'phone': '414-955-4903'}], 'overallOfficials': [{'name': 'Martin Hessner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Unidentified samples and data will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benaroya Research Institute', 'class': 'OTHER'}, {'name': 'Indiana University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Martin Hessner', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}