Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
Study NCT ID:
NCT04825795
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-03-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054873', 'term': 'Dipeptidyl-Peptidase IV Inhibitors'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4007}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-05', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of obstructive coronary disease', 'timeFrame': 'one year', 'description': 'Change in the prevalence of obstructive coronary disease, defined as \\>50 percent stenosis in coronary CT scan'}], 'secondaryOutcomes': [{'measure': 'Change in coronary calcium score', 'timeFrame': 'one year', 'description': 'Change in coronary calcium score, measured by two coronary CT scan per one year.\n\nAgatston score has minumum value of 0 and no maximum vavlue. Higher agatston score indicated severe calcification and worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The study aim is to evaluate whether DPP4-inhibitor could reduce coronary atherosclerosis assessed by CT scan in patients receiving insulin for diabetes mellitus. In this retrospective study, changes in obstructive coronary artery disease prevalence and coronary calcium burden between two coronary CT scans will be compared in patients with and without receiving DPP4-inhibitor.', 'detailedDescription': 'This is a retrospective study using medical records in two hospitals affiliated to the Catholic University of Korea. Patients with diabetes mellitus who received insulin are retrospectively enrolled. Among those, only patients who underwent coronary CT scan for more than two times will be included. Included patients will be classified into DPP4-inhibitor group and no DPP4-inhibitor group according to the prescribed medication. The changes in obstructive coronary artery disease prevalence and coronary calcium score per one year will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed with diabetes mellitus and receiving chronic insulin therapy will be enrolled. Among those, only patients who underwent more than two times of coronary CT scan will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus\n* Receiving chronic insulin therapy (prescription of insulin pen)\n* Who underwent more than 2 times of coronary CT scan\n\nExclusion Criteria:\n\n* Age \\<18'}, 'identificationModule': {'nctId': 'NCT04825795', 'briefTitle': 'DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Effect of DPP4 Inhibitors on Coronary Atherosclerosis in Patients With Diabetes Mellitus on Insulin Therapy', 'orgStudyIdInfo': {'id': 'XC21WIDI0044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DPP4-inhibitor', 'description': 'Patients who were prescribed DPP4-inhibitor during the period between two coronary CT scan.', 'interventionNames': ['Drug: DPP4-inhibitor']}, {'label': 'No DPP4-inhibitor', 'description': 'Patients who were not prescribed DPP4-inhibitor during the period between two coronary CT scan.', 'interventionNames': ['Drug: No DPP4-inhibitor']}], 'interventions': [{'name': 'DPP4-inhibitor', 'type': 'DRUG', 'description': 'Prescription of DPP4-inhibitor during the period between the two coronary CT scan', 'armGroupLabels': ['DPP4-inhibitor']}, {'name': 'No DPP4-inhibitor', 'type': 'DRUG', 'description': 'No prescription of DPP4-inhibitor during the period between the two coronary CT scan', 'armGroupLabels': ['No DPP4-inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KS013', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': "Bucheon St. Mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'overallOfficials': [{'name': 'Sang-Hyun Ihm, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data, because the clinical medical records using in this study are not open to public.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Hyun Ihm, MD PhD', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}