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11 February 2012
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| [ Print-friendly version ] |
| Thiamine supplementation in type 2 diabetes |
| ISRCTN | ISRCTN30703970 |
| ClinicalTrials.gov identifier | |
| Public title | Thiamine supplementation in type 2 diabetes |
| Scientific title | 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 |
| Acronym | N/A |
| Serial number at source | PHT/2009/36 |
| Study hypothesis |
It is well known that people with type 2 diabetes are more prone to circulatory related diseases (heart attack, stroke) when compared with individuals without diabetes. It is thought that this is related to problems with the function of the lining of blood vessels (endothelium), an increase in generalised inflammation within the blood vessels and various other factors including over-production of harmful by-products (oxidative stress). The changes in the endothelium that occur subsequently contribute to blocking of the arteries (atherosclerosis) which can lead to heart attack or stroke.
Similar mechanisms to those just described have been implicated in the development of other complications of type 2 diabetes such as kidney and eye disease as well as the development of type 2 diabetes itself. Traditional risk factors for this include smoking, raised cholesterol, excess weight and family history and these have all been extensively studied. However despite modification of these risk factors the occurrence of these diabetes and these complications continues to rise and therefore further research is being done to look at other potential modifiable elements. Thiamine is a water soluble vitamin essential found naturally in raw foods. It is known that, despite a normal dietary intake of thiamine, people with diabetes have a lower level of thiamine in their blood compared to individuals without diabetes. It is an important regulator of glucose metabolism and some experimental studies have shown that thiamine may have a role in maintaining function of the endothelium. This study aims to investigate whether thiamine supplementation will have benefits in the way of reducing inflammation, reducing formation of harmful by-products and improving the body’s ability to use insulin. |
| Lay summary | |
| Ethics approval | Southampton B Research Ethics Committee (REC) pending approval as of 20/11/2009 |
| Study design | Single centre randomised placebo-controlled double blind crossover trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Type 2 diabetes mellitus |
| Participants - 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 ten years
2. HbA1c less than 10% 3. Between the ages of 18 and 75 years, either sex |
| Participants - 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) |
| Anticipated start date | 01/02/2010 |
| Anticipated end date | 02/08/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 34 |
| 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 treatment: 8 weeks each for thiamine or placebo Duration of follow-up: 18 weeks in which the participant is in the study |
| Primary outcome measure(s) | Change in VCAM-1 (vascular adhesion molecule-1) levels pre- and post-treament (baseline and 8 weeks). This is a surrogate marker of vascular inflammation. |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
1. Portsmouth Hospitals NHS Trust (UK) - Academic Department of Diabetes and Endocrinology
2. Diabetes UK (UK) - in process of applying for a small grant |
| Trial website | |
| Publications | |
| Contact name | Prof Michael Cummings |
| Address |
Academic Department of Diabetes and Endocrinology
Portsmouth Hospitals NHS Trust Southwick Hill Road Cosham |
| City/town | Portsmouth |
| Zip/Postcode | PO6 3LY |
| Country | United Kingdom |
| michael.cummings@porthosp.nhs.uk | |
| Sponsor | Portsmouth Hospitals NHS Trust (UK) |
| Address |
Southwick Hill Road
Cosham |
| City/town | Portsmouth |
| Zip/Postcode | PO6 3LY |
| Country | United Kingdom |
| martine.cross@porthosp.nhs.uk | |
| Sponsor website: | http://www.porthosp.nhs.uk/ |
| Date applied | 20/11/2009 |
| Last edited | 04/01/2010 |
| Date ISRCTN assigned | 04/01/2010 |
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