Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-01 @ 12:20 AM
Study NCT ID:
NCT06757751
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2024-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2024-12-27', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin (HbA1c)', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks'}, {'measure': 'Fasting plasma glucose (FPG)', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mg/dl'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'Years'}, {'measure': 'Sex at birth', 'timeFrame': 'Baseline', 'description': 'Male/female'}, {'measure': 'Cardiovascular Risk Factors', 'timeFrame': 'Baseline', 'description': 'Cardiovascular risk factors from the following list will be indicated:\n\nArterial hypertension: Yes/No Dyslipidemia: Yes/No\n\nSmoking:\n\nNon-smoker Current smoker Recent ex-smoker (\\<1year) Former smoker (≥1year)'}, {'measure': 'Hepatic dysfunction', 'timeFrame': 'Baseline', 'description': 'Yes/No'}, {'measure': 'Previous heart disease', 'timeFrame': 'Baseline', 'description': 'Yes/No'}, {'measure': 'Heart failure', 'timeFrame': 'Baseline', 'description': 'Yes/No'}, {'measure': 'Coronary Heart Disease', 'timeFrame': 'Baseline', 'description': 'Yes/No\n\nIf yes, answer the following questions:\n\n* Acute coronary syndrome: Yes/No\n* Coronary revascularization: Yes/No'}, {'measure': 'Concomitant pharmacological treatment', 'timeFrame': 'Baseline', 'description': 'The concomitant pharmacological treatment will be indicated by marking the appropriate one in the following list:\n\nDiuretics: Yes/No Mineralcorticoid receptor antagonists: Yes/No ACE inhibitors: Yes/No ARBs2: Yes/No Sacubitril/Valsartan: Yes/No Ivabradin: Yes/No Statins: Yes/No AntiPCSK9: Yes/No Ezetimibe: Yes/No Fibrates: Yes/No Antiaggregants: Yes/No Anticoagulants: Yes/No Beta-blockers: Yes/No Calcium antagonists: Yes/No Antiarrhythmics: Yes/No'}, {'measure': 'Antidiabetic treatment', 'timeFrame': 'Baseline', 'description': 'Antidiabetic treatment: Yes/No\n\nIf Yes, will indicate which of the following list:\n\nMetformin: Yes/No Sulfonylurea: Yes/No I-DPP4: Yes/No I-SGLT2: Yes/No ArGLP1: Yes/No Pioglitazone: Yes/No Insulin: Yes/No\n\nIf insulin is "Yes", which type of dose from the following list will be indicated:\n\nBasal (1); Two-dose NPH or premixes (2); Basal-bolus (3); Total daily dose: IU/day'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mm Hg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mm Hg'}, {'measure': 'Heart rate', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'beats/minute'}, {'measure': 'Weight', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'kg'}, {'measure': 'Heigth', 'timeFrame': 'Baseline', 'description': 'cm'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline', 'description': 'kg/m2'}, {'measure': 'Urinary albumin excretion (UAE)', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mg/24 h'}, {'measure': 'Estimated Average Plasma Glucose', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mg/dl'}, {'measure': 'Fasting Insulin', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'µU/ml'}, {'measure': 'Homeostatic Model Assessment for beta-cell function (HOMA-B)', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'Adimensional'}, {'measure': 'N-terminal pro-B-type natriuretic peptide (NT-proBNP)', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'pg/ml'}, {'measure': 'Total cholesterol', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mg/dl'}, {'measure': 'LDL-C HDL-C, mmol/l', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mg/dl'}, {'measure': 'HDL-C', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mg/dl'}, {'measure': 'Triglycerides (TG)', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'mg/dl'}, {'measure': 'Dietetic education', 'timeFrame': 'At baseline, at 12 weeks and at 24 weeks', 'description': 'Visit with Dietitian: Yes/No'}, {'measure': 'Cardiovascular events', 'timeFrame': 'At 12 weeks and at 24 weeks', 'description': 'It will be indicated if cardiovascular events have occurred: Yes/No'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Since Galician virgin olive oils have a high content of bioactive phenolic compounds and these are attributed to a large part of the healthy properties of the Mediterranean Diet, our starting hypothesis is that these olive oils could attenuate insulin resistance, improving glycemic control in terms of fasting plasma glucose and/or glycated hemoglobin and insulin sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes mellitus for at least 1 year prior to inclusion.\n* Older than 18 years old\n* Current treatment with diet and/or oral hypoglycemic agents (biguanides, thiazolindiones, α-glucosidase inhibitors, iDPP4, aGLP-1, iSGLT2).\n* Body mass index ≥ 25 kg/m2 and \\< 40 kg/ m2.\n\nExclusion Criteria:\n\n* Patients on treatment with insulin, SU or rapid-acting insulin secretagogues.\n* History of severe ketosis or hyperglycemic decompensation.\n* Pregnancy, pregnancy planning or breastfeeding.\n* Body mass index ≥ 25 kg/m2 and \\< 40 kg/m2.\n* Difficulty or great inconvenience in changing eating habits or a low predicted probability of changing eating habits.\n* Serious medical condition that may affect the person's ability to participate in a nutritional intervention study (e.g., digestive disease with fat intolerance, malignant disease, or significant neurological, psychiatric, or endocrine disease).\n* Any other medical condition considered to limit survival to less than 1 year.\n* Immunodeficiency or HIV positive status.\n* Illegal drug use, chronic alcoholism or problematic alcohol use or total daily alcohol intake \\> 80 g/d.\n* Participation in any clinical trial or use of any investigational drug within the past year.\n* Patients institutionalized for chronic care."}, 'identificationModule': {'nctId': 'NCT06757751', 'acronym': 'OILDIABET', 'briefTitle': 'Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes Mellitus.', 'organization': {'class': 'OTHER', 'fullName': 'Fundacin Biomedica Galicia Sur'}, 'officialTitle': 'Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'OILDIABET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'For 24 weeks, subjects in this arm will have their diet supplemented, daily, with an amount of 30 ml of EVOO (Extra Virgin Olive Oil).\n\nSubjects in this arm will also receive qualitative dietary recommendations for following a healthy diet from the nutritional recommendations for patients with diabetes (Evert et al. (2013). Diabetes Care, 36 (11), 3821-3842.).', 'interventionNames': ['Dietary Supplement: EVOO diet supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Subjects in this arm will receive qualitative dietary recommendations for following a healthy diet from the nutritional recommendations for patients with diabetes (Evert et al. (2013). Diabetes Care, 36 (11), 3821-3842.).'}], 'interventions': [{'name': 'EVOO diet supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'For 24 weeks, subjects in intervention arm will have their diet supplemented, daily, with an amount of 30 ml of EVOO (Extra Virgin Olive Oil).', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32004', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Beatriz Cancho Grande', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacin Biomedica Galicia Sur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Beatriz Cancho Grande', 'investigatorAffiliation': 'Fundacin Biomedica Galicia Sur'}}}}