Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT01900834
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2013-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Monthly venous blood samples within the first half year and thereafter bi-monthly the rest of the year. A subgroup of the subjects will also be invited for a visit within a week after the former visit to assess the variation of the biomarkers within a week. The blood samples will be assayed for peripheral blood mononuclear cells (PBMC) specificity, phenotype and function as well as for islet autoantibodies (presence and precise titers), for autoantibody isotypes and diabetes risk parameters. Finally C-peptide levels and residual beta cell function will be measured three times during the study after a mix meal tolerance test (MMTT) in subjects with T1D.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2013-06-28', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in CD8 (cluster of differentiation) +T-cell specificity profiling', 'timeFrame': 'Over a one year period'}], 'secondaryOutcomes': [{'measure': 'Variation in CD4 +T-cell specificity profiling', 'timeFrame': 'Over a one year period'}, {'measure': 'Change in stimulated C-peptide', 'timeFrame': 'Baseline, one year'}, {'measure': 'Fluctuation in islet autoantibodies titers', 'timeFrame': 'Over a one year period'}, {'measure': 'Variation in HbA1c (glycosylated haemoglobin)', 'timeFrame': 'Over a one year period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with T1D, T2D and healthy subjects (HS) without personal or first degree family history of autoimmunity of diabetes. The HS will be mean age-matched with the T1D subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* T1D\n* Male or female subjects diagnosed within the last 3 years and with good general health based on medical history\n* Age above or equal to 14 years and below or equal to 40 years\n* Body weight above 45 kg\n* T2D\n* Male or female subjects diagnosed within the last 15 years with good general health based on medical history\n* HbA1c between 6.5% and 10%\n* Body mass index (BMI) below 45 kg/m\\^2\n* Age above or equal to 18 and below 65 years\n* On insulin treatment\n* HS\n* Male or female subjects with good general heath based on medical history\n* Age above or equal to 18 years and below or equal to 40 years\n\nExclusion Criteria:\n\n* Any chronic disorder (besides T1D or T2D) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol\n* Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant"}, 'identificationModule': {'nctId': 'NCT01900834', 'briefTitle': 'Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period', 'orgStudyIdInfo': {'id': 'INS-4099'}, 'secondaryIdInfos': [{'id': 'U1111-1140-1650', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'The participants will not receive any treatment', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR,1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}