Diabete Type 2
Conditions
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
Brief summary
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.
Interventions
DIETARY_SUPPLEMENT3 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.
Sponsors
University Tunis El Manar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in lipid profile | Between M3 ( week 12) and M0 (baseline) | Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol |
| change in oxidative stress markers | Between M3 ( week 12) and M0 (baseline) | MDA (malondialdehyde) SOD ( Superoxide Dismutase) pentosidine TAC (Total Antioxidant Capacity) |
| Change in HbA1c | between M3 (Week 12) and M0 (baseline),) | — |
| Change in Fasting blood glucose | Between M3 ( week 12) and M0 (baseline) | — |
| change in Insulin resistance (HOMA-IR) | Between M3 ( week 12) and M0 (baseline) | Δ (M2-M0), calculated from fasting insulin and glucose (standard formula). |
Secondary
| Measure | Time frame |
|---|---|
| Weight's variation | Between M3 ( week 12) and M0 (baseline) |
| change in Body Mass Index | Between M3 ( week 12) and M0 (baseline) |
| change in blood pressure | Between M3 ( week 12) and M0 (baseline) |
Countries
Tunisia
Contacts
CONTACTCHAYMA BEL HADJ SLIMAN, Hospital-University Physician
Outcome results
None listed