We established a central coordinating site in the UK and national coordinating sites in Australia and Canada. A total of 32 subsidiary sites were established across the three countries.
UK Participating Sites
Click to expand
Australian participating sites
Click to expand
Canadian participating sites
Click to expand
We screened 4,407 young people with type 1 diabetes (age 10 – 16 years) across three countries (UK, Australia, Canada) to take part in AdDIT, each providing six early morning urine samples (2 sets of 3) which were tested for protein levels (albumin). The amount of protein in the urine is a good indicator of renal function (the lower the better) and is a predictor for the future risk of kidney, retinal and heart complications.
Allocated
Based on the level of protein measured in their urine samples, we then allocated those screened to one of three risk groups (tertiles): upper, middle and lower.
Recruited
Those young people with higher than average protein levels (upper tertile) were invited into the intervention study, to help us investigate if ACE inhibitors (blood pressure) or statin (Cholesterol lowering) drug therapy in young people reduces their future risk for complications.
We conducted what is called a double-blind placebo controlled trial. This meant that, neither the participants nor the doctors or nurses knew if they were taking an active drug or a placebo (dummy) drug. To decide which combination of tablets participants would take, we randomised each to one of four groups (see Figure 1 below).
Young people who were at low risk, (middle and lower tertiles) of developing complications of diabetes were invited to join the observation study, to provide data that could be compared with those in the high risk group and help understanding risk factors and mechanisms implicated in the development of complications of diabetes.
Figure 1
Data collection
We then followed up participants for a minimum of 2 years and maximum of 4 years. Study visits were planned, where possible to coincide with regular clinic visits and we collected a range of data including; blood and urine samples, height, weight, blood pressure, safety data, cIMT scans, retinal photos.