Oral thiamine (Vitamin B1) supplementation in subjects with type 2 diabetes mellitus: a randomised, double-blind, placebo-controlled crossover trial assessing biophysical markers of endothelial function, oxidant stress, insulin sensitivity and vascular inflammation - Thiamine supplementation in type 2 diabetes.

Conditions: Type 2 diabetes

Registration Number: EUCTR2009-017537-21-GB

Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 34

Inclusion Criteria

•Individuals with a diagnosis of type 2 diabetes mellitus with a more than 30% chance of cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease) over the next ten years.
•HbA1c less than 10%
•Between the ages of 18 and 75
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Established cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease)
•Allergy/intolerance to thiamine supplementation
•Insulin treatment
•Diuretic treatment
•Current multivitamin/thiamine therapy
•Abnormal thyroid function
•Chronic excess alcohol consumption/impaired liver function (>21 units per week in females, >28 units per week in males; Department of Health Guidelines)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aims of the study are to test whether thiamine supplementation has an effect on:-<br><br>a)Improving function and reducing inflammation of the lining of the blood vessels (endothelium)<br>b)Reducing the production of harmful by-products of various chemical reactions in the body (oxidative stress)<br>c)Allowing the body to use insulin more efficiently in people with diabetes (insulin sensitivity)<br>;Secondary Objective: To see whether there is any association between the thiamine related changes in the functioning of the lining of blood vessels, reduction in harmful by-products and the bodies effectiveness of using insulin.;Primary end point(s): The primary outcome measure for the study is the change in VCAM-1, as a measure of endothelial function, seen following administration of Thiamine versus placebo.

Secondary Outcome Measures