Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 12:27 AM
Study NCT ID:
NCT07375069
Status:
RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes treatment adherence according to the most recent European Guidelines', 'timeFrame': '12-24-36-48 months', 'description': 'Outpatients clinic treatment adherence will be measured as the percentage of patients receiving guideline-directed medical therapy prescriptions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'CardioMET is an observational, multicenter, real-life registry, intending to collect data on patients with Type 2 Diabetes Mellitus, attending internal medicine and cardiology outpatient clinics. The aim of the registry is to characterize the cardiovascular risk profile and pharmacological management of Type 2 Diabetes Mellitus in Italy, in accordance with current ESC and AHA guidelines for primary and secondary prevention of CV disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive diabetic patients attending the outpatient clinics, in primary and secondary prevention of cardiovascular disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Diagnosis of type 2 diabetes mellitus (T2DM);\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected liver disease;\n* Patients with type 1 diabetes mellitus;\n* Cardiac surgery or percutaneous coronary revascularization scheduled within the next 3 months;\n* Patients with acute inflammatory or infectious diseases during the previous 3 months;\n* Patients with chronic inflammatory, immune, or infectious diseases;\n* Patients with ongoing malignant neoplasms;\n* History of alcohol, drug, or medication abuse;\n* Clinically significant hematological disorders;\n* Systemic steroid treatment within the last 6 months;\n* Acute-phase metabolic disorders;\n* Any condition that may put the patient at risk by participating in the study.'}, 'identificationModule': {'nctId': 'NCT07375069', 'acronym': 'CardioMET', 'briefTitle': 'Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy - CardioMET Registry', 'orgStudyIdInfo': {'id': 'Prot. 189/2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'data collection', 'type': 'OTHER', 'description': 'Data collection on diabetes therapy and follow-up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pasquale Perrone Filardi', 'role': 'CONTACT', 'email': 'fpperron@unina.it', 'phone': '+39081/7462224'}], 'facility': 'Federico II University of Naples, Department of Advanced Biomedical Sciences', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Pasquale Perrone Filardi', 'role': 'CONTACT', 'email': 'fpperron@unina.it', 'phone': '+39081/746224'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pasquale Perrone Filardi', 'investigatorAffiliation': 'Federico II University'}}}}