Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT)

AdDIT is a large multi-centre, multi-national intervention study looking at the effect of ACE inhibitors and statins in adolescents with Type 1 Diabetes and high albumin excretion. It is funded by Diabetes UK, the JDRF and the BHF and has been adopted by MCRN and DRN. Support for the study has also been provided by Pfizer.

Background

The prognosis for childhood-onset Type 1 Diabetes is poor; adolescence appears to be a critical period in determining the future lifetime risk of nephropathy and cardiovascular disease.

During adolescence, rapid growth and poor glycaemic control contribute to the complication risk associated with microalbuminuria. Early intervention in adolescence with ACE inhibitors and statin therapy may provide cardio-renal protection in high risk subjects resulting in long-term improvements in prognosis.

Aim of Study

To determine in a 2x2 factorial double blind placebo controlled parallel group trial whether intervention with ACE inhibitors, Statins or a combination of both drugs in high risk subjects will:

•         Reduce albumin excretion and prevent decline in renal function

•         Reduce CVD risk

•         Be well tolerated by patients

•         Be a cost effective treatment

Study Population

500 participants across 6 UK sites (Cambridge, Oxford, Birmingham, Bristol, Manchester and Newcastle), 5 sites in Australia (Perth, Westmead, Adelaide, Sydney and Victoria) and Canada (Toronto).

Inclusion Criteria

•    Age 11-15 yrs

•        T1DM diagnosed more than 1 year or C-peptide negative

•         High risk (upper tertile based on 6 early morning urines) of developing diabetic nephropathy and cardiovascular disease

Exclusion Criteria

•         Non T1DM

•         Albumin excretion in low risk range

•         Pregnancy, or unwillingness to comply with contraceptive advice and regular pregnancy testing

 •         Familial hypercholesterolaemia

•         Prior exposure to statin or ACEI

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