Extrait

Background and study aims Type 1 diabetes is caused by the body’s own white blood cells damaging the insulin-producing cells in the pancreas. The pancreas is then unable to produce any insulin, a hormone that normally controls the amount of sugar (glucose) in the blood. This results in the blood glucose level becoming too high. The aim is to develop a treatment that can slow or stop this process by switching off the white blood cells causing the damage. This treatment involves a molecule similar to insulin attached to small particles of gold (nanoparticles). The aim of this study is to investigate whether this treatment is safe with no significant side-effects. Who can participate? Patients aged between 18 and 40 with type 1 diabetes What does the study involve? Participants have a blood test to assess whether they have the right tissue type for the study. If suitable, they are asked to attend their local research centre for a general examination and further blood and urine tests. If the participant still has some insulin response after the post-meal urine test they are given the first injection. Each participant has three injections of the same treatment, given 4 weeks apart. During the treatment, participants undergo various tests including blood and urine tests and lymph node tissue samples (biopsies). A follow-up appointment takes place 6 weeks after the last injection. What are the possible benefits and risks of participating? Participants will have more time with staff members to discuss their diabetes and ask questions than at a routine clinic appointment. It is not known whether receiving the injections will be of benefit, as this is the first study where the treatment is being used in humans. Possible side effects include bruising and discomfort at the site of the blood test and lymph node tests, local redness and swelling reactions at the site of the injections, and severe allergic reaction to the injection requiring treatment, such as steroids, adrenaline or fluids. Where is the study run from? 1. Cardiff & Vale University Health Board (UK) 2. Linköping University Hospital (Sweden) When is the study starting and how long is it expected to run for? August 2016 to December 2018 Who is funding the study? Seventh Framework Programme Who is the main contact? 1. Prof. Colin Dayan ([email protected]) 2. Julie Pell ([email protected])

Critère d'inclusion

• Type 1 Diabetes

Liens

• isrctn