Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:11 PM
Study NCT ID:
NCT07431359
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Dietary Knowledge and the Habit of Using the Mediterranean Diet in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Nutritional Knowledge Score (NK)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Studies often show average scores around 50-60% of correct answers. Knowledge is often measured as a percentage of a total possible score, with a 75% threshold sometimes used to define "basic" or "good" knowledge.'}, {'measure': 'Mediterranean Diet Adherence (AMD) value', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'High Mediterranean Diet Adherence (AMD) is strongly linked to a reduced risk of developing and progressing to advanced Age-Related Macular Degeneration (AMD), with studies showing 34% to 60% lower risk compared to low adherence. A diet rich in vegetables, fruits, and nuts significantly lowers this risk.'}], 'secondaryOutcomes': [{'measure': 'Hand Grip test', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'muscle strength parameters'}, {'measure': 'fasting blood glucose (mg/dL)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'metabolic compensation parameters'}, {'measure': 'glycated haemoglobin (mmol/mol)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'metabolic compensation parameters'}, {'measure': 'lipid profile (mg/dL)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'metabolic compensation parameters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'mediterranean diet', 'nutrition'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to evaluate nutritional knowledge and adherence to the Mediterranean diet through the administration of questionnaires in patients with type 2 Diabetes Mellitus belonging to Outpatient Diabetology Service of the Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population of this study consists of patients affected by Type 2 Diabetes belonging to the Diabetology Service of the Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2DM in nutritional and/or pharmacological euglycemic treatment (metformin, gliptins, gliflozines, incretin mimetics, pioglitazone)\n* Signing of informed consent\n\nExclusion Criteria:\n\n* Patient with Diabetes Mellitus type 1\n* Patients with insulin T2DM treated'}, 'identificationModule': {'nctId': 'NCT07431359', 'acronym': 'REALDIAB', 'briefTitle': 'Evaluation of Dietary Knowledge and the Habit of Using the Mediterranean Diet in Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Casa di Cura Dott. Pederzoli'}, 'officialTitle': 'RELATIONSHIP Between ALimentary Knowledge and Adherence to the Mediterranean Diet in Patients With DIABete Mellito Type 2 Attending an Outpatient Service (REALDIAB)', 'orgStudyIdInfo': {'id': '599CET'}}, 'armsInterventionsModule': {'interventions': [{'name': 'administration of questionnaires - Collection of Clinical Parameters - Hand Grip Test', 'type': 'OTHER', 'description': 'The acquisition of personal and clinical information and the data obtained from the questionnaires will be carried out in conjunction with the usual control visits planned as part of normal clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37019', 'city': 'Peschiera del Garda', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Grazia Zenti, MD', 'role': 'CONTACT', 'email': 'urc@ospedalepederzoli.it', 'phone': '+39 0456444193'}], 'facility': 'Ospedale P. Pederzoli Casa di Cura Privata S.p.A.', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa di Cura Dott. Pederzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}