Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:17 AM
Study NCT ID:
NCT07467967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'between M3 (Week 12) and M0 (baseline),)'}, {'measure': 'Change in Fasting blood glucose', 'timeFrame': 'Between M3 ( week 12) and M0 (baseline)'}, {'measure': 'change in oxidative stress markers', 'timeFrame': 'Between M3 ( week 12) and M0 (baseline)', 'description': 'MDA (malondialdehyde)\n\nSOD ( Superoxide Dismutase)\n\npentosidine\n\nTAC (Total Antioxidant Capacity)'}, {'measure': 'change in lipid profile', 'timeFrame': 'Between M3 ( week 12) and M0 (baseline)', 'description': 'Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol'}, {'measure': 'change in Insulin resistance (HOMA-IR)', 'timeFrame': 'Between M3 ( week 12) and M0 (baseline)', 'description': 'Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).'}], 'secondaryOutcomes': [{'measure': "Weight's variation", 'timeFrame': 'Between M3 ( week 12) and M0 (baseline)'}, {'measure': 'change in Body Mass Index', 'timeFrame': 'Between M3 ( week 12) and M0 (baseline)'}, {'measure': 'change in blood pressure', 'timeFrame': 'Between M3 ( week 12) and M0 (baseline)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dates (Phoenix dactylifera)', 'Antioxidants', 'Polyphenols', 'Oxidative Stress', 'Diabetes Mellitus, Type 2', 'Blood Glucose', 'Glycated Hemoglobin A (HbA1c)', 'Insulin Resistance', 'Metabolic Control', 'Body Mass Index', 'Waist Circumference', 'Blood Pressure', 'Lipid Profile', 'Prospective Studies', 'Nutritional Status', 'Dietary Intervention'], 'conditions': ['Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'Summary\n\nDates, rich in simple sugars, fiber, and antioxidant polyphenols, have a variable glycemic index and conflicting reported effects on type 2 diabetes. Moderate consumption might raise glycemia if added to the usual diet, but could improve insulin sensitivity and oxidative balance if used as an isocaloric substitute.\n\nThis prospective, interventional, single-center study (Endocrinology Department., La Rabta Hospital, Tunis) aims to evaluate the effect of daily consumption of 3 Deglet Nour dates for 8 weeks on glycemic control and oxidative stress in 130 well-controlled type 2 diabetic patients.\n\nPrimary objectives:\n\nAssess changes in HbA1c, fasting glucose, and HOMA-IR. Measure variations in oxidative stress markers (MDA, SOD, TAC, pentosidine).\n\nSecondary objectives:\n\nMonitor changes in weight, BMI, waist circumference, and blood pressure. Assess tolerance, adherence, satisfaction, and adverse events.\n\nStudy design:\n\nBaseline and final visits (week 0 and week 8) with clinical, dietary, and laboratory assessments.\n\nIsocaloric substitution: 3 dates replace a carbohydrate portion (e.g., fruit or dessert).\n\nNo change in antidiabetic therapy or lifestyle allowed.\n\nEndpoints:\n\nPrimary: ΔHbA1c, Δfasting glucose, ΔHOMA-IR, and oxidative markers. Secondary: Anthropometrics, blood pressure, safety, adherence, lipid and metabolic parameters.\n\nExpected outcome: determine whether moderate, isocaloric date consumption is safe and potentially beneficial for metabolic control and oxidative balance in Tunisian patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Type 2 diabetes diagnosed for at least one year\n* Well-controlled diabetes on oral antidiabetic drugs for at least 3 months, with a target baseline HbA1c \\< 8%\n* Duration of diabetes \\< 15 years\n* Patient available for an 8-week period\n* Written informed consent\n\nNon-inclusion Criteria:\n\n* Patients on insulin therapy\n* Oral antidiabetic treatment modified within the 3 months prior to inclusion\n* Diabetes with established microvascular or macrovascular complications\n* Severe intercurrent diseases (severe renal insufficiency, severe liver disease, cardiovascular history, neoplasia, inflammatory disease)\n* Pregnancy or breastfeeding\n* Known allergy or intolerance to dates\n* Dietary regimens incompatible with isocaloric substitution (e.g., strict ketogenic diet, prolonged fasting)\n* Inability to understand or comply with study instructions (cognitive impairment, language barrier without interpreter, major logistical constraints)\n\nExclusion Criteria:\n\n* Initiation of insulin therapy or major modification of antidiabetic treatment\n* Occurrence of pregnancy during the study\n* Development of a serious adverse event attributable to the intervention (e.g., persistent hyperglycemia, acute metabolic complications)\n* Patient refusal to continue the study or withdrawal of informed consent\n* Major non-adherence to the intervention (\\<80% of planned intake or absence of isocaloric substitution)\n* Detection of a severe intercurrent condition requiring discontinuation of the intervention (e.g., heart failure decompensation, severe infection)\n* Loss to follow-up preventing the assessment of primary endpoints'}, 'identificationModule': {'nctId': 'NCT07467967', 'briefTitle': 'Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'RE002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Type 2 diabetic patients', 'description': 'Adults aged 18-65 years with type 2 diabetes diagnosed for at least one year, well-controlled on oral antidiabetic therapy for at least 3 months (baseline HbA1c \\< 8%), with a disease duration of less than 15 years, available for an 8-week study period, and providing written informed consent.', 'interventionNames': ['Dietary Supplement: 3 dates per day consumption']}], 'interventions': [{'name': '3 dates per day consumption', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention is date fruit consumption (3 dates per day) incorporated into the daily diet of patients with type 2 diabetes, following an isocaloric substitution plan for a duration of 8 weeks.', 'armGroupLabels': ['Type 2 diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'La Rabta Hospital , Endocrinology Department', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'CHAYMA BEL HADJ SLIMAN, Hospital-University Physician', 'role': 'CONTACT', 'email': 'bhschaima@yahoo.com', 'phone': '+21655204179'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital-University Physician', 'investigatorFullName': 'Chayma Bel Hadj Sliman', 'investigatorAffiliation': 'University Tunis El Manar'}}}}