Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 5:06 PM
Study NCT ID:
NCT03805633
Status:
WITHDRAWN
Last Update Posted:
2019-12-13
First Post:
2018-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Person working on the trial left', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glucose during oral glucose tolerance test (oGTT)', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Change in C peptide over oGTT', 'timeFrame': 'Baseline'}, {'measure': 'Change in insulin response oGTT', 'timeFrame': 'Baseline'}, {'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoidosis', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the characteristics of patients with diabetes and sarcoidosis and to compare them with those of patients with diabetes and no sarcoidosis. The investigators will approach these aims by measuring hemoglobin A1c, C peptide, insulin levels, and 2-hour glucose tolerance test results on the study population as well as collecting clinical data from records. Three groups of patients will be identified from pulmonary and endocrinology clinics at the University of Alabama at Birmingham. The first group will have a diagnosis of sarcoidosis without diabetes, the second group will have a diagnosis of both sarcoidosis and diabetes, and the third group will have a diagnosis of diabetes without sarcoidosis. Sample size is not pre-determined, but investigators anticipate this number to be less than 100. These patients will be asked in person during an office visit to join the study. For each patient who agrees to join, at a clinic visit, investigators will review and sign consent. Following the visit or at a time convenient for each patient, study subjects will undergo a fasting plasma venous sample collection for a hemoglobin A1c, C peptide, insulin level and perform a 2-hour oral glucose tolerance test. The degree of glucose intolerance and prevalence of diabetes will be analyzed and compared between the groups and to historical published control data via T test comparisons. At a later separate visit, patients recruited will undergo ultrasound of the pancreas to assess pancreatic size and morphology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One group will consist of patients referred to or followed at UAB pulmonary clinic with an established diagnosis of sarcoidosis without diabetes mellitus. A second group will consist of patients referred to or followed at UAB pulmonary and/or endocrinology clinic with diagnoses of both sarcoidosis and diabetes mellitus. A third group will consist of patients referred to or followed at UAB endocrinology clinic with a diagnosis of diabetes mellitus without sarcoidosis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient referred to or followed in UAB pulmonary clinic with an established diagnosis of sarcoidosis. Any adult patient followed in UAB endocrinology clinic with a diagnosis of diabetes mellitus (excluding type 1 diabetes).\n\nExclusion Criteria:\n\n* Type 1 diabetes and/or chronic use of corticosteroids.'}, 'identificationModule': {'nctId': 'NCT03805633', 'briefTitle': 'A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'IRB-300000289'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sarcoidosis Patients', 'description': 'Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.', 'interventionNames': ['Diagnostic Test: Venous blood sample', 'Diagnostic Test: Ultrasound of pancreas']}, {'label': 'Diabetes Patients', 'description': 'Patients followed by UAB Endocrinology with diabetes mellitus.', 'interventionNames': ['Diagnostic Test: Venous blood sample', 'Diagnostic Test: Ultrasound of pancreas']}, {'label': 'Sarcoidosis and Diabetes patients', 'description': 'Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus.', 'interventionNames': ['Diagnostic Test: Venous blood sample', 'Diagnostic Test: Ultrasound of pancreas']}], 'interventions': [{'name': 'Venous blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.', 'armGroupLabels': ['Diabetes Patients', 'Sarcoidosis Patients', 'Sarcoidosis and Diabetes patients']}, {'name': 'Ultrasound of pancreas', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound of pancreas will be obtained on all study participants.', 'armGroupLabels': ['Diabetes Patients', 'Sarcoidosis Patients', 'Sarcoidosis and Diabetes patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'starting 1 month after publication', 'ipdSharing': 'YES', 'description': 'All collected individual participant data (IPD)', 'accessCriteria': 'IPD will be shared with future participating researchers who are not yet identified (future fellow physicians).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Professor', 'investigatorFullName': 'Fernando Ovalle', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}