Type 1 Diabetes Clinical Trial
Official title:
Randomised, Double Blind, Placebo Controlled Trial of Angiotensin Converting Enzyme Inhibitors and Statins in the Prevention of Long Term Complications in Young People With Type 1 Diabetes
The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.
Subjects will be recruited from a pre-screened population of 3,000 young people with T1D aged
10 to 16 years based on assessment of risk for future CVD and DN.
They will be randomised to a 2 x 2 factorial design contrasting the effects of ACEI, statins,
or combination therapy to placebo over a maximum four year treatment period. Minimisation of
variation in albumin excretion rate, gender, age, diabetes duration, HbA1c, total cholesterol
and centre site will be undertaken at randomisation.
Analysis of the primary endpoint, change in albumin excretion will be undertaken on an
intention to treat basis. Secondary analyses will be undertaken on the basis of 'as treated'
allowing for variance in compliance and allowing for subjects who show substantial change in
HbA1c levels. Additional analyses will be undertaken to assess changes in the secondary
objectives and to assess the overall effect of the intervention on quality of life and health
economics.
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