Extrait

Background and study aims Blood vessel damage in diabetes, and probably in people who are overweight, is a major threat to the health of anyone with the condition. There is strong evidence that people with diabetes develop stiffening of their arteries due to excess scar formation in blood vessel walls. We want to test whether a treatment usually given for high blood pressure and a vegetable juice can help prevent the scarring and improve blood vessel function. Who can participate? Men and women aged 18 to 80 years with diagnosed Type 2 diabetes, or at risk of diabetes, for example by being overweight and found to have raised blood sugar. What does the study involve? If you decide to take part and are suitable for the study we will ask you to come to the Clinical Research Facilities (St Thomas’ Hospital or King’s College Hospital) for a screening visit where we will measure your blood pressure (BP), height, weight and ask you questions about your medical history, we will then take a blood sample and a urine sample. If you are eligible, we will then use non-invasive and painless devices to measure the health of your blood vessels. The devices generally use a simple cuff (as used for blood pressure). During these, we will ask you to keep still for a few minutes while we fit and inflate cuffs around your ankles and arms. There is also a small cuff on one side of the neck which is not inflated above 60mmHg (less tight than a man’s tie). They have all been found to be entirely safe. We will also measure the number of small vessels in your finger with a simple, painless microscope, which takes about 5 minutes. An Electrocardiogram (ECG) and an Echocardiogram to assess how well the heart pumps will be offered to you at the start and end of the study. These measures will be repeated up to 5 times in the study, after 2 weeks, then every 3 months from the start of the treatment for 1 year. Visits will be required after 2 weeks after starting treatment and at month 2 where we will only take a blood sample and measure your BP. If you are willing we will also ask you to collect your urine for 24h 3 to 4 times during the study and ask you to wear a cuff on your arm measuring your BP for 24h, which also measures blood vessel stiffness. At your second visit we will provide you with the treatment to take during the study. This will be pills, either as spironolactone or doxazosin – which both lower BP and a beetroot juice or a control juice (beetroot juice but without Nitrate). You take these pills and juice daily with your current treatment. These treatments are allocated by ‘randomization’, that is purely by chance as generated by computer. Neither you nor we decide which treatment you will receive; also neither you nor we will know which you are taking until the study ends, so that it will not affect the results. What are the possible benefits and risks of participating? You will have regular vascular and blood pressure check up that goes beyond your routine care. We will check your kidney function often and we will contact you if there are any problems. At the end of the study you will receive the results of all your tests. We will reimburse you travel expenses for a maximum of £15 per visit and some refreshment will be provided at the end of each visit. Taking blood samples may cause minor discomfort with a small chance of minor bruising. Many measures of BP can make the arm feel a bit squeezed and leave a few marks which go soon after. Vascular measures are very similar to BP. Most people have no problems with either type of pill but as always, some people have ‘side-effects’. These are not common but see list below here. For spironolactone, the blood potassium increases a little (harmless unless it goes very high, usually when kidney function is impaired, which is why we measure it at the start and through the study). Other rarer problems can include a skin rash and in men some tenderness in the nipples (very rare in women). Occasionally, problems with erectile function can occur in men but ’viagra-like’ treatment helps (this can be provided free by your GP). Doxazosin has few problems but dizziness can occur. Where is the study run from? St Thomas’ Hospital or King’s College Hospital (UK) When is the study starting and how long is it expected to run for? The recruitment will run from February 2013 for 2 years. Who is funding the study? FUKUDA Denshi Japan Who is the main contact? Virginia Govoni [email protected]

Critère d'inclusion

• Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease, Hypertension, Diabetic Control, Nutrition, Pre Diabetes

Liens

• ictrp
• isrctn