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 in
Completed Phase 2 ISRCTN30703970
Study Description
Background and study aims People with diabetes mellitus are at increased risk of developing heart disease and strokes. Thiamine is a vitamin that is needed by the body to regulate blood sugar levels and may also be involved in preventing heart disease. This study aims to see whether giving additional thiamine can reduce the risk of developing heart disease. Who can participate? This study is looking for 34 participants aged between 18 and 70 who are known to have type 2 diabetes. What does the study involve? This study will take place over a 5-month period and participants will need to attend for four visits each lasting about 2 hours. On the first visit you will need to undergo a routine physical examination and have an ECG (tracing of your heart). At each of the visits you will need to have fasted from the evening before, provide a sample of urine (to test for protein levels) and undergo blood tests (30 ml of blood) to check your kidneys, liver, blood fat levels, insulin sensitivity, thiamine levels, and diabetes control. We will then assess the function of the lining of the blood vessels using a probe that is applied to your fingertip (this is painless) attached to a specialised machine. We repeat the finger-probe test after administration of GTN spray under the tongue and again following administration of inhaled salbutamol via a spacer device. These medications are usually used for angina and asthma respectively and work by temporarily dilating the blood vessels. At the doses used in the study they have rare mild side effects which include transient headache and a metallic taste in the mouth. After the first visit you will be given either thiamine tablets to be taken once a day or a placebo (dummy) equivalent. You are to take these tablets for 8 weeks and then return for the same protocol of urine, blood and finger-probe testing as described above. You will then be given a minimum 2-week break before the same testing procedure will be repeated with a further 8-week administration of thiamine or placebo (whichever you did not receive the first time). The blood samples taken during the study will be stored for up to 12 months after completion of the study and may be analysed for other markers that may be related to circulatory disease. What are the possible benefits and risks of participating? The aim is to see whether thiamine can help reduce the risk of developing diseases such as heart attacks and stroke while also improving a persons general diabetic health. Therefore, although the study will not specifically benefit your diabetic/medical care, the results may be beneficial in the care of many patients with diabetes in the future. The Food Standards Agency has shown that the oral administration of thiamine is safe and non-toxic. A small number of individuals may show an allergic response to lower doses but reports of these events are rare. Where is the study run from? The study will be run from Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust (UK). When is the study starting and how long is it expected to run for? The study ran from February 2010 to August 2011. Who is funding the study? All study funding is coming from internal departmental budgets. Who is the main contact? Dr Georgina Page gljpage@gmail.com
Study Details
- Registry ID:
- ISRCTN30703970
- Conditions:
- Type 2 diabetes mellitus, Nutritional, Metabolic, Endocrine
- Phase:
- Phase 2
- Target Enrollment:
- 34 participants
- Start Date:
- Age Range:
- 18–999 years
- Healthy Volunteers:
- No
Interested in Participating?
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