Thiamine supplementation in type 2 diabetes

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30703970

Enrollment

Registered

2010-01-04

Start date

2010-02-01

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Thiamine (vitamin B1/thiamine hydrochloride) versus placebo. Thiamine is being given orally at a dose of 300 mg daily for 8 weeks. Total duration of treatment: 8 weeks each for thiamine or placebo Du

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026