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45 Years
75 Years
Not Enrolling
Diabetes Type 2

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Trial Information

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Change in insulin resistance(HOMA)from baseline to 12th week

Outcome Description:

HbA1c with measurement of plasma glucose and insulin (to determine HOMA) from baseline to the 12th week of product intake

Outcome Time Frame:

D0 (baseline), D28 and D114

Safety Issue:


Principal Investigator

Stephen L Atkin, MD, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Head of Academic Endocrinology, Diabetes & Metabolism; Hull York Medical School; Michael White Diabetes Centre, Hull, UK


United Kingdom: National Health Service

Study ID:




Start Date:

April 2009

Completion Date:

May 2011

Related Keywords:

  • Diabetes Type 2
  • diabetes type 2
  • insulin resistance
  • glycaemic control
  • Endothelial function
  • Cocoa Polyphenols
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2