Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes

N/ANot Yet RecruitingNCT07467967

University Tunis El Manar130 enrolled

Overview

Summary Dates, 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. This 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. Primary objectives: Assess changes in HbA1c, fasting glucose, and HOMA-IR. Measure variations in oxidative stress markers (MDA, SOD, TAC, pentosidine). Secondary objectives: Monitor changes in weight, BMI, waist circumference, and blood pressure. Assess tolerance, adherence, satisfaction, and adverse events. Study design: Baseline and final visits (week 0 and week 8) with clinical, dietary, and laboratory assessments. Isocaloric substitution: 3 dates replace a carbohydrate portion (e.g., fruit or dessert). No change in antidiabetic therapy or lifestyle allowed. Endpoints: Primary: ΔHbA1c, Δfasting glucose, ΔHOMA-IR, and oxidative markers. Secondary: Anthropometrics, blood pressure, safety, adherence, lipid and metabolic parameters. Expected 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

130

Conditions

Diabete Type 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-65 years * Type 2 diabetes diagnosed for at least one year * Well-controlled diabetes on oral antidiabetic drugs for at least 3 months, with a target baseline HbA1c \< 8% * Duration of diabetes \< 15 years * Patient available for an 8-week period * Written informed consent Non-inclusion Criteria: * Patients on insulin therapy * Oral antidiabetic treatment modified within the 3 months prior to inclusion * Diabetes with established microvascular or macrovascular complications * Severe intercurrent diseases (severe renal insufficiency, severe liver disease, cardiovascular history, neoplasia, inflammatory disease) * Pregnancy or breastfeeding * Known allergy or intolerance to dates * Dietary regimens incompatible with isocaloric substitution (e.g., strict ketogenic diet, prolonged fasting) * Inability to understand or comply with study instructions (cognitive impairment, language barrier without interpreter, major logistical constraints) Exclusion Criteria: * Initiation of insulin therapy or major modification of antidiabetic treatment * Occurrence of pregnancy during the study * Development of a serious adverse event attributable to the intervention (e.g., persistent hyperglycemia, acute metabolic complications) * Patient refusal to continue the study or withdrawal of informed consent * Major non-adherence to the intervention (\<80% of planned intake or absence of isocaloric substitution) * Detection of a severe intercurrent condition requiring discontinuation of the intervention (e.g., heart failure decompensation, severe infection) * Loss to follow-up preventing the assessment of primary endpoints

Outcomes