Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05605704
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2022-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Olive Leaf Extracts in the Control of Diabet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Active Comparator: atherolive group Placebo Comparator: placebo group'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In each study population, the patient will be assigned to one of two treatments (atherolive or placebo) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-01', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-10-29', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of continuous glycemic monitoring and Hemoglobin A1C', 'timeFrame': '90 days', 'description': 'Patients will be fitted with an iPro continuous glycemic monitoring (CGM) recorder (Medtronic, Northridge, CA) for 24 consecutive hours on an outpatient basis . A CGM (Enlite Sensor) sensor is inserted into abdominal (or arm) fatty tissue subcutaneously and calibrated according to Medtronic standard operating guidelines. The iPro Continuous Glucose Recorder measures interstitial subcutaneous tissue glucose levels continuously, recording values every 5 minutes, over a range of 40-400 mg/dL.recorded data will be downloaded for analysis of glucose profile and glucose excursion parameters with the CareLink iPro system. Analysis will be performed on the data obtained within the 24-hour period after placement.'}], 'secondaryOutcomes': [{'measure': 'variation in lipid balance', 'timeFrame': '90 days', 'description': 'Rate of variation in lipid balance'}, {'measure': 'rate of hospitalization for cardiovascular disease and adverse effects', 'timeFrame': '90 days', 'description': ', rate of hospitalization for cardiovascular disease : acute infarction, hypertension, acute stroke as well as number of adeverse events reported'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'Atherolive'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).\n\nPatients over 18 years of age with:\n\n-Diabets', 'detailedDescription': 'This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).\n\nAll the population will benifit of a biological assessment which include:\n\n* Complete lipid profile, blood sugar, creatinine\n* HbA1c (if the patient is diabetic).\n* Inflammatory assessment: reactive protein C One population will be rendomized:The population with diabetes. In each study population, the patient will be assigned to one of two treatments (atherolive or placebo). The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.\n\nContinuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. These patients will be equipped with an iPro continuous glycemic monitoring'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age with:\n* diabetes.\n\nExclusion Criteria:\n\n* Exclusion criteria: None.'}, 'identificationModule': {'nctId': 'NCT05605704', 'acronym': 'Dia-Athr', 'briefTitle': 'Olive Leaf Extracts in the Control of Diabet', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Diabet', 'orgStudyIdInfo': {'id': 'Diab-Atherolive'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'atherolive', 'description': 'In this Arm the patient will receive the study drug (atherol) that will be prescribed at a dose of 400 mg, once a day for 3 months.', 'interventionNames': ['Drug: Atherolive']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo atherolive', 'description': 'In this Arm patients will receive the placebo at a dose of 400 mg once a day for 3 months.', 'interventionNames': ['Drug: Placebo Atherolive']}], 'interventions': [{'name': 'Atherolive', 'type': 'DRUG', 'description': 'The patient will be assigned using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months.', 'armGroupLabels': ['atherolive']}, {'name': 'Placebo Atherolive', 'type': 'DRUG', 'description': 'The patient will be assigned using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The placebo will be prescribed at a dose of 400 mg once a day for 3 months.', 'armGroupLabels': ['placebo atherolive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Monastir Tunisia', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Semir Nouira', 'role': 'CONTACT', 'email': 'semir.nouira.urg@gmail.com', 'phone': '73106000'}], 'facility': 'Semir Nouira', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'centralContacts': [{'name': 'Nouira semir, Pr', 'role': 'CONTACT', 'email': 'semir.nouira@rns.tn', 'phone': '73106046', 'phoneExt': '216'}, {'name': 'Bel Hadj Ali khaoula, MD', 'role': 'CONTACT', 'email': 'belhadjalikhaoula@yahoo.fr', 'phone': '73106046', 'phoneExt': '216'}], 'overallOfficials': [{'name': 'Nouira Semir, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical proffesor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}