Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Type 2 diabetic patients
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 < 8%), with a disease duration of less than 15 years, available for an 8-week study period, and providing written informed consent.
干预措施: 3 dates per day consumption (Dietary Supplement)
结局指标
主要结局
Change in HbA1c
时间窗: between M3 (Week 12) and M0 (baseline),)
Change in Fasting blood glucose
时间窗: Between M3 ( week 12) and M0 (baseline)
change in oxidative stress markers
时间窗: Between M3 ( week 12) and M0 (baseline)
MDA (malondialdehyde) SOD ( Superoxide Dismutase) pentosidine TAC (Total Antioxidant Capacity)
change in lipid profile
时间窗: Between M3 ( week 12) and M0 (baseline)
Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol
change in Insulin resistance (HOMA-IR)
时间窗: Between M3 ( week 12) and M0 (baseline)
Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).
次要结局
- 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))
研究者
Chayma Bel Hadj Sliman
Hospital-University Physician
University Tunis El Manar