Thiamine supplementation in type 2 diabetes.

• Research type

  Research Study

• Full 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

• IRAS ID

  33021

• Contact name

  M H Cummings

• Sponsor organisation

  Portsmouth Hospitals NHS Trust

• Eudract number

  2009-017537-21

• ISRCTN Number

  n/a

• Research summary

  Both the development of diabetes and its associated complications has been linked to problems with the function of the lining of blood vessels (endothelium), an increased generalised inflammation and over-production of harmful by-products (oxidative stress), processes which may be integrally linked. Thiamine is a water soluble vitamin found naturally in raw foods and, despite normal dietary intake, people with diabetes have a lower level of thiamine in their blood compared with 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 may reduce inflammation, reduce formation of harmful by-products and improving the body's ability to use insulin.34 patients will be recruited via the Diabetes Database at Queen Alexandra Hospital and the study will take place over a 5-month period for each patient at the Diabetes centre, Queen Alexandra Hospital. 4 visits will be required from each subject. Each visit is expected to last approximately 2 hours and will involve physical examination, blood and urine sampling and assessment of endothelial function, done non-invasively using a finger-probe. The subjects will be randomised to receive either thiamine or placebo once daily for 8-weeks. A 2-week washout period will then be undertaken before cross over to placebo or thiamine for a further 8-weeks. The investigations will be repeated at the beginning and the end of each 8-week intervention. Patient identification for recruitment will occur via the Portsmouth Hospital Diabetes Database.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/137

• Date of REC Opinion

  11 Jan 2010

• REC opinion

  Further Information Favourable Opinion