Thiamine supplementation in type 2 diabetes

Phase 2

Completed

Conditions: Type 2 diabetes mellitus
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Registration Number: ISRCTN30703970

Lead Sponsor: Portsmouth Hospitals NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 34

Inclusion Criteria

1. 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 10 years
2. HbA1c less than 10%
3. Between the ages of 18 and 75 years, either sex

Exclusion Criteria

1. Established cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease)
2. Allergy/intolerance to thiamine supplementation
3. Insulin treatment
4. Diuretic treatment
5. Current multivitamin/thiamine therapy
6. Abnormal thyroid function
7. Chronic excess alcohol consumption/impaired liver function (greater than 21 units per week in females, greater than 28 units per week in males; Department of Health Guidelines)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VCAM-1 (vascular adhesion molecule-1) levels pre- and post-treatment (baseline and 8 weeks). This is a surrogate marker of vascular inflammation.

Secondary Outcome Measures

Name	Time	Method
Measured at 8 weeks:<br>1. Measurement of endothelial dysfunction determined by the reflection index of the digital volume waveform using photoplethysmography<br>2. Measurement of insulin sensitivity (pancreatic B-cell function [HOMA-B] method)<br>3. Markers of oxidant stress (total antioxidant status [TAOS], lipid hydroperoxides [LHP], cyclic guanosine monophosphate [cGMP], glutathione [GSH]/oxidised glutathione [GSSG])<br>4. Markers of vascular inflammation (high sensitivity C-reactive protein [hsCRP] and albumin/creatinine ratio [ACR])<br>5. Glycaemic control (HbA1c, fructosamine)<br>6. Lipid parameters