Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT05681533
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2022-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epicardial Adipose Tissue and Arterial Stiffness in People Living With Diabetes (METAB-CV-PWV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-26', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-26', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epicardial fat volume', 'timeFrame': 'the inclusion visit', 'description': 'Epicardial fat volume will be determined using cardiac CT scan without contrast injection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabet', 'arterial stiffness', 'pericardial adipose tissue'], 'conditions': ['Diabetic Patients']}, 'referencesModule': {'references': [{'pmid': '41094476', 'type': 'DERIVED', 'citation': 'Koutcha ON, Tatulashvili S, Sritharan N, Boutouyrie P, Rezgani I, Boubaya M, Mariko ML, Allard L, Sal M, Bloch-Queyrat C, Zerguine M, Brillet PY, Fekih ZE, Bruno RM, Bihan H, Cosson E. Epicardial adipose tissue volume and arterial stiffness in people living with diabetes: the METAB-CV-PWV study. Cardiovasc Diabetol. 2025 Oct 15;24(1):400. doi: 10.1186/s12933-025-02933-z.'}]}, 'descriptionModule': {'briefSummary': 'The present study is a retrospective and prospective current care cohort that will allow us to evaluate the relationship between epicardial fat volume and increased arterial stiffness in a person living with diabetes.', 'detailedDescription': 'Epicardial adipose tissue is considered as the cardiac visceral fat and is associated with increased cardiovascular risk, for example in diabetes. Thus, the mechanisms involved seem to be related to myocardial lipotoxicity; atherosclerosis in connection with inflammation and secretion of proinflammatory factors such as cytokines but also insulin resistance.\n\nIn this context, the investigators hypothesize that epicardiac adipose tissue volume will be higher in patients with increased arterial stiffness than in those without. In this study, the investigators will then try to verify the existence of a relationship between pericardial adipose tissue volume and increased arterial stiffness in people living with diabetes.\n\nTo do this, the investigators will analyze the results of measurements of pericardial fat volume, coronary calcium score, and pulse wave velocity in diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 or 2 diabetic patients who perform coronary calcium score measurement by CT scan and pulse wave velocity assessment as part of their routine care practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will be eligible for participation in the study if:\n\n* They are informed and have not objected to participating in the research.\n* They have type 1 or 2 diabetes.\n* They perform a coronary calcium score measurement by CT scan and a pulse wave velocity assessment during their routine care practice.'}, 'identificationModule': {'nctId': 'NCT05681533', 'acronym': 'METAB-CV-PWV', 'briefTitle': 'Epicardial Adipose Tissue and Arterial Stiffness in People Living With Diabetes (METAB-CV-PWV)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Tissu Adipeux épicardique et rigidité artérielle Chez Les Personnes Vivant Avec un diabète', 'orgStudyIdInfo': {'id': 'APHP220876'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT scan', 'type': 'PROCEDURE', 'description': 'coronary calcium score measurement by CT scan'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel COSSON, Pr', 'role': 'CONTACT', 'email': 'emmanuel.cosson@aphp.fr'}], 'facility': 'endocrinologie site, Avicenne hospital', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'centralContacts': [{'name': 'Emmanuel COSSON, Pr', 'role': 'CONTACT', 'email': 'emmanuel.cosson@aphp.fr', 'phone': '01 48 95 51 54'}, {'name': 'Omar NOUHOU KOUTCHA, Dr', 'role': 'CONTACT', 'email': 'omarnouhou1@gmail.com', 'phone': '07 64 18 07 14'}], 'overallOfficials': [{'name': 'Emmanuel COSSON, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP, Hospital Avicenne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}