Tim Jones; Liz Davis
Study Staff: Alison Roberts; Vinutha Shetty; Mary Abraham; Martin de Bock; Adam Retterath; Jennifer Nicholas; Julie Dart
This is an international clinical trial with the primary objectives of determining whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, will: (1) reduce albumin excretion as assessed by six monthly measurement of albumin/creatinine ratio (ACR) in 3 early morning urines; (2) reduce the incidence of microalbuminuria (MA) (ACR log mean > 3.5 mg/mmol (males) or > 4 mg/mmol (females) in 2 out of 3 urines) at the end of the study period; (3) reduce the incidence of MA during the six month run out period following the completion of intervention phase.
This study will aim to recruit 500 adolescents with the following criteria: adolescents aged 11-16years; with type 1 diabetes of >1year duration; identified as being at high risk for the development of DN and CVD as predicted by albumin excretion in the upper tertile afterappropriate adjustment for age, sex, age at diagnosis and duration of disease. Recruitment closed in December 2012. It is a four-armed randomised clinical trial involving: (1) Quinapril: starting dose 5mg increased to 10mg daily after 2 weeks ,(2) Atorvastatin, 10mg daily, (3) Quinapril + Atorvastatin, (4) Placebo.
Funders: JDRF; BHF