NCT07467967Not yet recruiting
Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 8 Mar 2026
- Start date
- 15 Jul 2026
- Primary completion date
- 20 Feb 2027
- Lead sponsor
- University Tunis El Manar
- Diseases
- Type 2 diabetes
- NCT number
- NCT07467967
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 15 Jul 2026 to the primary completion date, 20 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation of insulin therapy or major modification of antidiabetic treatment
Other illness
- Detection of a severe intercurrent condition requiring discontinuation of the intervention (e.g., heart failure decompensation, severe infection)
Other
- 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)
- Loss to follow-up preventing the assessment of primary endpoints
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| La Rabta Hospital , Endocrinology Department Coordinator of this site? Confirm its status | Tunis | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.