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

Обзор

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.

Вмешательства

• Пищевая добавка 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.

Первичные конечные точки

• Change in HbA1c [Срок оценки: between M3 (Week 12) and M0 (baseline),)]
• Change in Fasting blood glucose [Срок оценки: Between M3 ( week 12) and M0 (baseline)]
• change in oxidative stress markers [Срок оценки: Between M3 ( week 12) and M0 (baseline)]
• change in lipid profile [Срок оценки: Between M3 ( week 12) and M0 (baseline)]
• change in Insulin resistance (HOMA-IR) [Срок оценки: Between M3 ( week 12) and M0 (baseline)]

Вторичные конечные точки (3)

• Weight's variation [Срок оценки: Between M3 ( week 12) and M0 (baseline)]
• change in Body Mass Index [Срок оценки: Between M3 ( week 12) and M0 (baseline)]
• change in blood pressure [Срок оценки: Between M3 ( week 12) and M0 (baseline)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Tunisia · 1 центр

• La Rabta Hospital , Endocrinology Department — Tunis

Идентификаторы

NCT: NCT07467967 · RE002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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