The effect of dietary intake of Fruit and Vegetables on vascular function in type two Diabetes mellitus

Completed

Conditions: Type two diabetes and vascular disease
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Registration Number: ISRCTN21676269

Lead Sponsor: Royal Victoria Hospital (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Male or female
2. Aged 40 - 70 years
3. Type two diabetes on diet and/or oral hypoglycaemic therapy

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in endothelial function as measured by venous occlusion plethsymography and pulse wave analysis/velocity.

Secondary Outcome Measures

Name	Time	Method
Change in biochemical measures of vascular function:<br>1. Total cholesterol<br>2. High density lipoprotein (HDL)-cholesterol<br>3. High sensitivity C-reactive protein (CRP)<br>4. Triglycerides<br>5. Plasma plasminogen activator inhibitor-1 (PAI-1)<br>6. Von Willebrand Factor<br>7. Plasma glucose<br>8. Serum insulin<br>9. HbA1c<br>10. Adhesion molecules<br><br>The subjects undergo assessment of vascular function at the end of the four-week washout period and the eight-week intervention period.