Australian Adolescent Type 1 Diabetes Intervention Trial (Aussie AdDIT) - to assess the prevalence and progression of microvascular and macrovascular disease in adolescents with Type-1 diabetes.

Not Applicable

Recruiting

• Conditions: Type-1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12610000573055
• Lead Sponsor: A/Professor Kim Donaghue

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

1. Aged 11-16 years
2. Type 1 diabetes for more than one year or C–peptide negative
3. Assessment of albumin-creatinine ratio in the upper or lower tertile

Exclusion Criteria

1. Albumin-creatinine ratio based on 6 early morning urines deemed to be in the middle tertile.
2. Non-type 1 diabetes
3. Severe hyperlipidaemia and family history data to support diagnosis of hyperlipidaemia.
4. Established hypertension unrelated to diabetic nephropathy
5. Prior exposure to statins and ACE inhibitors
6. Proliferative retinopathy
7. Other co-morbidities considered unsuitable by the investigator
8. Renal disease not associated with type 1 diabetes

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the prevalence and progression of microvascular and macrovascular disease where outcome measures include retinopathy (as assessed through retinal photography), aortic intima medial thickness (as assessed through ultrasound technique)and heart rate variability (as assessed through electrocardiogram (ECG).[Baseline and annually for 4 years]

Secondary Outcome Measures

Name	Time	Method
To assess the rate of progression of atherosclerosis and neuropathy in participants undergoing angiotensin-converting enzyme (ACE) inhibitor and statin treatment. Assessments include retinopathy (by retinal photography), aortic intima medial thickness (by ultrasound technique)and heart rate variability (by electrocardiogram (ECG).[Baseline and annually for 4 years]