Clinical trial of ACE inhibitors and statins in young people with type 1 diabetes

Adolescent type 1 diabetes cardio-renal intervention trial (AdDIT)

Young people diagnosed with type 1 diabetes during childhood are at risk of long term complications including kidney, heart and circulatory disease which may reduce life expectancy by 10-15 years. Although this risk can be reduced by improving control of blood glucose, adolescents often find it difficult to control blood glucose effectively. ACE inhibitors and statins are drugs used in adults to help protect the heart and kidneys by lowering blood pressure and lipid levels. However, they have not yet been evaluated in adolescents. This clinical trial, co-funded by the British Heart Foundation, Diabetes UK and Juvenile Diabetes Research Foundation, will find out if ACE inhibitors and statins are safe, effective and well tolerated in adolescents with type 1 diabetes. The study will screen 4,500 adolescents aged 11-15 in the UK, Australia and Canada to recruit 500 participants at high risk of complications and 400 participants at low risk. Participants in the high risk group will then be randomised to receive an ACE inhibitor, a statin, a combination of both or a placebo (dummy medication) and their progress will be studied over three to four years. They will have measurements of their kidney function, blood fat levels and scans to monitor the health of their arteries throughout the study period. The 400 participants in the low risk group will have similar measurements taken at the beginning and at the end of the study period. They will not be given any trial drug treatments but their results will provide important information about how blood vessel health and kidney function changes during adolescence in people with type 1 diabetes. If the AdDIT trial finds that ACE inhibitors and statins help to protect kidney and blood vessel function in the short term, these drugs could become new treatments for young people with type 1 diabetes.