Extrait

Background and study aims Diabetes is often complicated by the development of diabetic nerve disease (neuropathy). Diabetic neuropathy affects nerves that are outside of the brain and spinal cord, such as nerves in the arms, legs, hands and feet. Symptoms of diabetic neuropathy may include pain, such as a feeling of burning, prickling, tingling, aching, pins and needles usually occurring on both sides of the body affecting hands, legs or feet. Some patients may not be able to distinguish between sharp and dull and hot and cold (altered sensation). The aim of the study is to find out whether neuropathic pain in painful diabetic neuropathy is relieved by taking a tablet called taurine. Taurine occurs naturally in the body and it is thought that patients with painful diabetic neuropathy have less taurine in their body. By increasing the level of taurine in the body it is hoped that patients will experience less pain. This in turn may have the added benefit of improving quality of life. Who can participate? 180 patients from Diabetic Clinics at Heartlands and Solihull (UK) will be invited to take part in this study. You are eligible to take part if you have developed the complication of diabetes known as neuropathy and are 18-70 years old. What does the study involve? The patients will be randomly split into two groups. One group will receive the experimental drug and the second group will receive a dummy (placebo). Patients will be asked to attend a study visit to determine whether they are suitable to take part in this study. Tests will include a physical assessment (such as blood pressure and weight). An electrocardiogram (a painless test that records the electrical activity of your heart) will be performed. You will also have tests to determine the extent of your neuropathy, including your response to vibratory stimulation (tuning fork), cold detection (the difference between hot and cold) and comparisons made between areas on your body where you have pain and where you don’t. You will have an Autonomic Nerve Function Test performed on you. The test is painless and helps the study doctor decide whether you have neuropathy. You will be requested to attend the clinic for monthly physical assessments, collection of pain diaries and collection of the study drug to measure compliance. At three months a physical assessment will be performed including the above mentioned assessments of neuropathy. At a second visit, the pain and sleep diaries will be collected and any adverse events recorded. The questionnaires will again be administered and the experimental drug collected to measure compliance to the study. Four weeks after the study is completed, you will be contacted to assess how you are feeling now that the study drug has been stopped. What are the possible benefits and risks of participating? We hope that the treatment will help the pain in your feet. However, this cannot be guaranteed. The information we get from this study may help us to treat future patients with painful diabetic neuropathy more effectively. Where is the study run from? The majority of the visits will be held at Heart of England NHS Foundation Trust, and at least two visits will be completed at the Queen Elizabeth Hospital, Birmingham (UK). When is the study starting and how long is it expected to run for? October 2006 to December 2014 Who is funding the study? National Institutes of Health (USA) Who is the main contact? Prof. Martin J. Stevens, [email protected]

Critère d'inclusion

• Diabetic Neuropathy

Liens

• ictrp
• isrctn