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 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT01617603
Eligibility Criteria:
Inclusion criteria:
* The diagnosis of type 2 diabetes will be based on the WHO guidelines. These are 2 fasting plasma glucose readings of greater than 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 meeting 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.
* Diabetes managed by diet alone or diet and metformin. If metformin is used the dose should have been stable for a minimum of 3 months prior to the start of the study.
* Hba1c up to and including 9.9%
* Age 45-75
* If female, should be post-menopausal
* BMI 25-39kgm-2
* Patients will have attended a structured group patient education programme (and be on stable medication for hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study. Subjects will be encouraged to incorporate the chocolate into their diet as advised during the education programme
* Having obtained his/her or his/her legal representative's informed consent.
Exclusion Criteria:
* Patients with concurrent illness or any changes in medication in the last 3 months.
* Patients whose diabetes is managed with TZDs, DPP-IV inhibitors, GLP-1 analogues, insulin or sulphonylureas or prandial regulators
* Patients not wishing to allow disclosure to their GPs.
* Pregnancy
* Hba1c at recruiting stage of \>10.0%
* Patient who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* Patients who consuming more than 20g/d of chocolate or having a very high polyphenol content of their diet, who are not willing to change their diet
* Patients taking high dose antioxidant supplements including single and multivitamin preparations including A,C,E.
* Women on HRT treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT01617603
Study Brief:
Protocol Section:
NCT01617603