Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT04616066
Eligibility Criteria:
Inclusion Criteria:
* The diagnosis of type 2 diabetes will be based on the WHO guidelines. An HbA1C of 6.5% or greater, or 2 fasting plasma glucose readings of \>7.0mmoll-1 or 2 random plasma glucose readings \>11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meets the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed.
* Patients will be on stable medication for their diabetes, hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study.
* HbA1c 7.5 - 10%
* Patients between the ages of 45-75 years at the start of the study.
* Capable to give informed consent and complete the study.
Exclusion Criteria:
* Patients with concurrent illness or any medication in the last 3 months.
* Patients who are taking hormone replacement therapy.
* Patients who are currently or have taken antibiotics in the last 3 months.
* Currently enrolled in other clinical trials.
* Hba1c at recruiting stage of more than 10%.
* Patients with a BMI less than 20 and more than 40.
* Patients with known food allergies.
* Patients on insulin.
* Patients who are eating dates or raisins should be washed out for 4 weeks.
* Pregnant or nursing, or plans to become pregnant in the next 3 months, or not using adequate contraceptive measures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT04616066
Study Brief:
Protocol Section:
NCT04616066