[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628924":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":40,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":20,"eligibilityCriteria":49,"healthyVolunteers":46,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Tunis El Manar","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Dietary Supplement: 3 dates per day consumption",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"CHAYMA BEL HADJ SLIMAN, Hospital-University Physician","CONTACT","+21655204179","bhschaima@yahoo.com",[28],{"facility":29,"status":20,"city":30,"state":20,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":20},"La Rabta Hospital , Endocrinology Department","Tunis","1","Tunisia","TN",{"type":35,"coordinates":36},"Point",[37,38],10.16579,36.81897,{"lat":38,"lon":37},{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"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":54,"type":55},130,"ESTIMATED","INTERVENTIONAL",[58],"NA","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.",[61],"Diabete Type 2",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"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":82,"type":83},"2026-03-12","ACTUAL",{"date":85,"type":55},"2026-07-15",{"date":87,"type":55},"2027-12-31",{"name":5,"class":6},1]