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The Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) is a randomised, double blind, placebo controlled trial.

The primary objective is to determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, in a 2 x 2 factorial design over three to four years, 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 MA (ACR log mean > 3.5mg/mmol (males) or > 4mg/mmol (females) in 2 out of 3 urine) 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.

Summary of eligibility criteria

• Type 1 diabetes diagnosed for > 1 year
• Aged 11-16 years
• High risk for the development of DN and CVD as predicted by albumin excretion in the upper tertile after appropriate adjustment for age, sex, age at diagnosis and duration of disease.

Chief investigator

Professor David Dunger
University Department of Paediatrics
Box 116, Addenbrooke's Hospital
Hills Road, Cambridge, UK
CB2 0QQ

ISRCTN 91419926

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