[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628924":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":11,"studyPopulation":11,"armGroups":38,"interventions":45,"overallOfficials":11,"centralContacts":51,"locations":57,"responsibleParty":70,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":108,"whyStopped":11,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University Tunis El Manar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":11},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Change in HbA1c",null,"between M3 (Week 12) and M0 (baseline),)",{"measure":14,"description":11,"timeFrame":15},"Change in Fasting blood glucose","Between M3 ( week 12) and M0 (baseline)",{"measure":17,"description":18,"timeFrame":15},"change in oxidative stress markers","MDA (malondialdehyde)\n\nSOD ( Superoxide Dismutase)\n\npentosidine\n\nTAC (Total Antioxidant Capacity)",{"measure":20,"description":21,"timeFrame":15},"change in lipid profile","Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol",{"measure":23,"description":24,"timeFrame":15},"change in Insulin resistance (HOMA-IR)","Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).",[26,28,30],{"measure":27,"description":11,"timeFrame":15},"Weight's variation",{"measure":29,"description":11,"timeFrame":15},"change in Body Mass Index",{"measure":31,"description":11,"timeFrame":15},"change in blood pressure",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"NA","SINGLE_GROUP","PREVENTION",{"masking":37,"maskingDescription":11,"whoMasked":11},"NONE",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"Type 2 diabetic patients","EXPERIMENTAL","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 \\\u003C 8%), with a disease duration of less than 15 years, available for an 8-week study period, and providing written informed consent.",[44],"Dietary Supplement: 3 dates per day consumption",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"DIETARY_SUPPLEMENT","3 dates per day consumption","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.",[40],[52],{"name":53,"role":54,"phone":55,"phoneExt":11,"email":56},"CHAYMA BEL HADJ SLIMAN, Hospital-University Physician","CONTACT","+21655204179","bhschaima@yahoo.com",[58],{"facility":59,"status":11,"city":60,"state":11,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":11},"La Rabta Hospital , Endocrinology Department","Tunis","1","Tunisia","TN",{"type":65,"coordinates":66},"Point",[67,68],10.16579,36.81897,{"lat":68,"lon":67},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chayma Bel Hadj Sliman","Hospital-University Physician","100628924","impact-of-date-consumption-on-metabolic-control-and-oxidative-stress-in-patients-with-type-2-diabetes-100628924",false,"NCT07467967","Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes","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 \\\u003C 8%\n* Duration of diabetes \\\u003C 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 (\\\u003C80% 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","ALL","18 Years","65 Years",{"count":84,"type":85},130,"ESTIMATED","INTERVENTIONAL",[33],"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.",[90],"Diabete Type 2",[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"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","NOT_YET_RECRUITING","2026-03-08",{"date":111,"type":112},"2026-03-12","ACTUAL",{"date":114,"type":85},"2026-07-15",{"date":116,"type":85},"2027-12-31",{"name":5,"class":6},1]