Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06714058
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiometabolic Risk of Obese Subjects: Cross-sectional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'study-specific blood sampling for the evaluation of the expression profile of circulating miRNAs, the search for variants of the HMGA1 gene and the assay of the HMGA1 protein, of circulating biomarkers of inflammation and insulin resistance.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-11-28', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cycle threshold miRNAs', 'timeFrame': 'at baseline', 'description': 'Study of the expression profile of specific circulating miRNAs'}, {'measure': 'Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)', 'timeFrame': 'baseline', 'description': 'search for variants of the HMGA1 gene'}, {'measure': 'NGS sequencing of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.', 'timeFrame': 'baseline', 'description': 'NGS expression of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.'}, {'measure': 'Insulinemia (µU/mL)', 'timeFrame': 'baseline', 'description': 'Levels of haematic insulin'}, {'measure': 'C-peptide (nmol/L)', 'timeFrame': 'baseline', 'description': 'Levels of haematic of C-peptide'}, {'measure': 'thyrotropin (nmol/L)', 'timeFrame': 'baseline', 'description': 'Levels of haematic of thyrotropin'}, {'measure': 'HMGA1 protein assay', 'timeFrame': 'baseline', 'description': 'Levels of haematic HMGA1 protein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity and Obesity-related Medical Conditions', 'Cardiovascular Risk', 'Genetics']}, 'descriptionModule': {'briefSummary': 'experimental study with analysis on tissues. This study aims to study cardiometabolic risk from a genetic, clinical, instrumental and laboratory point of view in a population of subjects with obesity.', 'detailedDescription': 'Compared to normal clinical practice, if you decide to participate in the study you will be asked to:\n\n1. allow the collection of an additional study-specific amount of blood as part of a blood sample already provided for by clinical practice during the dietetic visit; The sample will be used to perform the genetic and laboratory analyses required by the study.\n2. Undergo an additional study-specific visit within one month of the dietetic visit. will be subjected to the measurement of the degree of vascular aging and the evaluation of the health of his/her arteries, through non-invasive examinations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients of both sexes, suffering from grade I obesity, not suffering from atheromatous cardiovascular diseases (ischemic heart disease, ischemic stroke, peripheral arterial disease)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Age \\> 18 years\n\n * BMI \\> 30 Kg/m2\n * In primary prevention for cardiovascular disease\n * Ability to communicate, make themselves understood and adhere to study-specific procedures\n * Willingness to participate in the study and obtain informed consent\n\nExclusion Criteria:\n\n* Patients already enrolled by the Research Units involved in the enrolment\n* Glycated hemoglobin level \\> 55 mmol/L\n* Patients suffering from obesity secondary to endocrinological diseases or iatrogenic causes\n* Patients with heterozygous Familial Hypercholesterolemia (Dutch Lipid Score - DLS\\>8)\n* Patients suffering from hypercholesterolemia secondary to lipid or iatrogenic extra-metabolic pathologies\n* Patients suffering from systemic inflammatory or oncological diseases\n* Patients on active treatment with GLP-1 analogues\n* Pregnancy and breastfeeding\n* Any medical or surgical condition that makes the patient's adherence to the study protocol complex or inconsistent."}, 'identificationModule': {'nctId': 'NCT06714058', 'acronym': 'MiRNome', 'briefTitle': 'Cardiometabolic Risk of Obese Subjects: Cross-sectional Study', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants', 'orgStudyIdInfo': {'id': 'MiRNome'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Letizia Petroni', 'role': 'CONTACT', 'email': 'marialetizia.petroni@unibo.it', 'phone': '+390512143281'}], 'facility': 'Maria Letizia Petroni', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Catanzaro', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Brunetti, Prof, MD', 'role': 'CONTACT', 'email': 'brunetti@unicz.it'}, {'name': 'Antonio Brunetti, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'centralContacts': [{'name': 'Maria Letizia Petroni, MD', 'role': 'CONTACT', 'email': 'marialetizia.petroni@unibo.it', 'phone': '+0512143281'}], 'overallOfficials': [{'name': 'Maria Letizia Petroni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}