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Evaluating ACEI and Statin Therapy in Adolescents with Type 1 Diabetes: The AdDIT Study

The Adolescent type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) investigates the effects of angiotensin-converting enzyme inhibitors (ACEI) and statins on high-risk adolescents with type 1 diabetes. With a focus on those exhibiting microalbuminuria, this multicenter, randomized, double-blind study assesses changes in albumin excretion and secondary outcomes such as cardiovascular markers and renal function over 3-4 years. The findings aim to enhance understanding of renal and cardiovascular protection in youths to prevent long-term complications associated with diabetes.

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Evaluating ACEI and Statin Therapy in Adolescents with Type 1 Diabetes: The AdDIT Study

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  1. The AdDIT Source: AdDIT Research Group. Adolescent type 1 Diabetes Cardio-renal Intervention Trial (AdDIT). BMC Pediatr. 2009;9:79.

  2. Background: In children and young people, the diagnosis of diabetes remains poor, thereby exposing them to the long-term risk of developing vascular complications. Diabetic neuropathy (DN) and cardiovascular disease (CVD) can be identified by the presence of microalbuminuria, which is often detected in adolescence, but is rarely treated before the age of 18 years. After puberty, levels of albumin excretion may decline even returning to normal levels in some individuals. Transient and persistent microalbuminuria in puberty/adolescence may lead to renal damage, thereby reno-protection is important to prevent long-term complications. In adults with diabetes and microalbuminuria, the use of angiotensin-converting enzyme inhibitors (ACEI) and statins is increasing, and hence the effect of these classes of drugs in adolescents needs to be studied.

  3. Aim: To determine whether ACEI and statins are of any value in the adolescent population.

  4. Methods: • Study design: The Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT) is a multicenter, randomized, double-blind, placebo-controlled trial of ACEI and statin therapy in adolescents with type 1 diabetes. • Number of patients: 500 high-risk adolescents [defined on the basis of their albumin excretion]. • Intervention: ACEI (quinapril), or statins (atorvastatin), or combination therapy, or placebo for 3–4 years. • There will also be a parallel open observational study, based on the follow-up of 400 low-risk non-randomized adolescents. • Primary endpoint: Change in albumin excretion. • Secondary endpoints: Markers of CVD, renal function, retinopathy, and quality of life combined with assessment of compliance and potential health economic benefits.

  5. Conclusion: What we can expect from AdDIT: • It will provide important data on the potential renal and cardiovascular protective effects of ACEI and statins in high-risk adolescents. • If long-term follow-up is continued, it may provide evidences of disease outcomes, in addition to the data on early surrogate measures of DN and CVD. • Potential impact of intervention of DN and CVD can be determined by the follow-up of non-randomized low-risk subjects. • Pharmacological cardio-renal protection should be implemented in addition to maintaining good glycemic control.

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