Extract

Background and study aims Type 1 diabetes mellitus (T1DM) is a lifelong condition where a person is unable to prevent their blood sugar (glucose) levels from becoming too high. When a person is suffering from TD1M, the body is unable to produce a hormone called insulin, which is responsible for breaking down glucose and turning it into energy. The only effective way of treating T1DM is by regularly injecting the insulin that the body is unable to produce. It is very important that sufferers take their insulin regularly, as otherwise it can lead to serious complications, such as damage to the heart and blood vessels (cardiovascular system) and kidneys (renal system). The risk of these complications seems to be higher in people diagnosed early in life, during childhood and adolescence when compared to people diagnosed during adulthood. The Adolescent type 1 diabetes cardio-renal intervention study (AdDIT) is a study aiming to evaluate drugs acting on blood pressure (ACE inhibitors) and lipid (fat) levels (statins) in adolescents with T1DM at risk of developing cardiovascular and renal complications. The AdDIT follow up study aims to look at the long term risk of developing these complications in adolescents who took part in the AdDIT study. Who can participate? Adolescents aged 10-16 who have type 1 diabetes and are at risk of developing cardiovascular or kidney disease. What does the study involve? In the AdDIT study, participants are randomly allocated to one of four groups who receive different drugs for 2-4 years. Those in the first group receive a statin (cholesterol-lowering drug) and placebo (dummy drug), those in the second receive a statin and an ACE inhibitor (blood pressure-lowering drug), those in the third group receive an ACE inhibitor and a placebo, and those in the fourth group receive two placebos. For all participants, at the start of the study and then yearly until the end, samples are taken to measure for signs of kidney or cardiovascular disease. In the AdDIT follow up study, participants from the AdDIT study are followed up for a further five years in order to find out whether the drugs used are able to protect against development of cardiovascular kidney disease in the long-term. What are the possible benefits and risks of participating? There are no direct benefits for AdDIT participants, but the study results will help in the future in improving the management of type 1 diabetes in young people with type 1 diabetes. During the AdDIt trial period study participants mayexperience some of the sides effects associated with statins or ACE inhibitors, but close monitoring will reduce risk of any relevant risk. There are no notable benefits or risks associated with the AdDIt follow up study. Where is the study run from? 1. University of Cambridge Addenbrookes Hospital (UK) 2. Hospital for Children, Perth (Australia) 3. The Hospital for Sick Children, Totonto (Canada) When is the study starting and how long is it expected to run for? August 2008 to December 2012 (AdDIT) August 2016 to December 2021 (AdDIT follow up) Who is funding the study? 1. Diabetes UK (UK) 2. Juvenile Diabetes Research Foundation (UK) 3. British Heart Foundation (UK) Who is the main contact? 1. Professor David Dunger (AdDIT) 2. Ms Rowena Weighell (AdDIT follow up)

Inclusion criteria

• Diabetic nephropathy and cardiovascular disease

Links

• isrctn
• ictrp