Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-03 @ 7:48 AM
Study NCT ID:
NCT02389335
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roles of T Helper 1 Cytokines in Type 1 Diabetes
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2015-03-10', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes', 'timeFrame': '3 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 1diabetes', 'IFN γ', 'IL-2', 'TNF α'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction.', 'detailedDescription': 'T helper (h)1 cells are known to have important roles in the destruction or/and dedifferentiation of β-cells in type 1 diabetes (T1D). Significant increase in IFN-γ-producing Th1 cells in the pancreas and in the serum levels were determined in type 1 diabetic patients at diabetes oneset. This data indicated that this proinflammatory mediator serve as a biomarker of advanced autoimmunity. We aimed to investigate the relationship between Th1 cytokines (IFN-γ, IL-2 and TNF-α) and T1D and the effect of those cytokines on β-cell function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 98 T1DPs and 30 healthy subjects (CG). All subjects\n\nwere matched on age and gender. β-cell function of 98 T1DPS was assesseed by measuring C-Peptide levels\n\nafter mixed-meal tolarence test (MMTT)s. T1DPs were divided into 3\n\ngroups according to the C-Peptide levels after MMTTs and the groups\n\nwere as follows: patients with undetectable ≤0.1 ng/mL(group 1a, n=30)\n\nC-Peptide levels; minimal 0.1-0.8 ng/mL(group1b, n=30); and sustained\n\n≥0.8ng/mL(group1c, n=38) C-peptide levels which increased at the 90th\n\nminute after the meal ≥150% of fasting C-peptide level.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients giving consent to participate the study\n* Patients with type 1 diabetes according to WHO definiton\n\nExclusion Criteria:\n\n* Acute and chronic inflammatory diseases,\n* significant concomitant diseases which may interfere with glucose metabolism\n* cancers,\n* hemoglobinopathies,\n* recently received antibiotics,\n* drugs influencing β-cell function and\n* insulin sensitivity or anti-inflammatory drugs\n* recent history of trauma'}, 'identificationModule': {'nctId': 'NCT02389335', 'briefTitle': 'Roles of T Helper 1 Cytokines in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'Roles of Interferon Gamma, Interleukin-2 and Tumor Necrotizan Factor Alpha in the Pathogenesis of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'MUGEAH-2'}, 'secondaryIdInfos': [{'id': 'Interleukins in type 1diabetes', 'type': 'REGISTRY', 'domain': 'Interleukins'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1a', 'description': 'Patients with type 1 diabetes who have undetectable c-peptide ( ≤0.1 ng/mL) levels after mixed meal tolarance test: group 1a'}, {'label': 'Group 1b', 'description': 'Patients with type 1 diabetes who have c-peptide levels between 0.1-0.8 ng/mL after mixed meal tolerance test: group 1b'}, {'label': 'Group 1c', 'description': 'Patients with type 1 diabetes who have c-peptide levels ≥0.8ng/mL after mixed meal tolerance test: group 1c'}, {'label': 'Control', 'description': 'Healthy subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34730', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medeniyet University Goztepe Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc prof', 'investigatorFullName': 'Gonca Incemehmet Tamer', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}