Type two diabetes and vascular disease Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
There is a four-week washout period where all 80 subjects take only one portion of fruit and vegetables per day. The subjects are then randomised to either one or six portions of fruit or vegetables f
Sponsors
Royal Victoria Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged 40 - 70 years 3. Type two diabetes on diet and/or oral hypoglycaemic therapy
Exclusion criteria
Exclusion criteria: 1. Any acute coronary event or surgery within the previous three months 2. Pregnant or lactating 3. Excess alcohol consumption (greater than 2 units/day for women, greater than 3 units/day for men) 4. Food sensitivities that would interfere with tolerance of fruit and vegetable consumption 5. Medical conditions that would substantially limit their ability to complete the study requirements 6. Ingestion of oral vitamins within the previous four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in endothelial function as measured by venous occlusion plethsymography and pulse wave analysis/velocity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in biochemical measures of vascular function: 1. Total cholesterol 2. High density lipoprotein (HDL)-cholesterol 3. High sensitivity C-reactive protein (CRP) 4. Triglycerides 5. Plasma plasminogen activator inhibitor-1 (PAI-1) 6. Von Willebrand Factor 7. Plasma glucose 8. Serum insulin 9. HbA1c 10. Adhesion molecules The subjects undergo assessment of vascular function at the end of the four-week washout period and the eight-week intervention period. | — |
Countries
United Kingdom
Outcome results
None listed