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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.

Aussie AdDIT - to assess retinal vascular changes, atherosclerosis and neuropathy in an identified sample of adolescents with Type 1 Diabetes Mellitus (T1DM) at low and high risk of microalbuminuria.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000573055
Acronym
Australian Adolescent Type 1 Diabetes Intervention Trial (Aussie AdDIT)
Enrollment
530
Registered
2010-07-16
Start date
2009-05-05
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The prognosis for childhood onset type 1 diabetes (T1D) remains generally poor with the number of life years lost is 17 years for a child diagnosed aged 10 years. Whilst in the second decade from diagnosis diabetic nephropathy (DN)accounts for around 60% of deaths, by the third decade cardiovascular disease (CVD) accounts for two thirds of all deaths. Although complications are rarely seen during childhood, there is evidence that their pathogenesis begins soon after diagnosis and accelerates during puberty. Adolescence may be a critical period for lifetime risk of complications in childhood onset diabetes. During puberty, the first signs of complications become evident. Microalbuminuria, an early risk marker for DN and CVD may be found in 12 to 16% of adolescents and this has been associated with renal pathology indicative of early nephropathy. This study is investigating the changes in retinopathy, aortic intima media thickness (aIMT) and heart rate variability which are indicators of macrovascular disease and autonomic neuropathy respectively. Diabetic retinopathy is the most common cause of blindness in young adults less than 40 years in the developed world. Factors affecting the genesis of autonomic neuropathy include glycaemic control, lipids and blood pressure. Studies have shown that atherosclerosis develops first in the abdominal aorta and precedes that seen in the carotid arteries. A study has reported that both high blood pressure and lipids increase neuropathy risk and it is likely therefore that intervention with ACE inhibitors and / or statin impact on neuropathy progression. Specific aims: a. To assess retinopathy (by retinal photography), atherosclerosis ( by aortic intima media thickness and carotid intima media thickness) and neuropathy (by heart rate variability) in an identified sample of adolescents with T1DM at high risk of microalbuminuria as compared to adolescents with T1DM at low risk of microalbuminuria. b. To determine whether ACE inhibition/statin therapy during puberty will reduce retinopathy, atherosclerosis and autonomic neuropathy progression in adolescents with T1DM at high risk of Microalbuminuria compared to adolescents with T1DM at low risk of Microalbuminuria.

Interventions

No intervention - observational study of T1DM in adolescents for a period of 4 years.

Sponsors

A/Professor Kim Donaghue
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
11 Years to 16 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026