EUCTR2009-017537-21-GBActive, not recruitingNot Applicable
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
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 34
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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)
Investigators
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