Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000573055
Ethics application status
Approved
Date submitted
14/07/2010
Date registered
16/07/2010
Date last updated
16/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 251992 0
Nil
Universal Trial Number (UTN)
U1111-1115-4841
Trial acronym
Australian Adolescent Type 1 Diabetes Intervention Trial (Aussie AdDIT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type-1 diabetes 257553 0
Condition category
Condition code
Metabolic and Endocrine 257714 257714 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention - observational study of T1DM in adolescents for a period of 4 years.
Intervention code [1] 256644 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258611 0
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).
Timepoint [1] 258611 0
Baseline and annually for 4 years
Secondary outcome [1] 264524 0
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).
Timepoint [1] 264524 0
Baseline and annually for 4 years

Eligibility
Key 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
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
530
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3044 0
2145
Recruitment postcode(s) [2] 3042 0
3052
Recruitment postcode(s) [3] 3045 0
4101
Recruitment postcode(s) [4] 3043 0
5006
Recruitment postcode(s) [5] 3041 0
6008

Funding & Sponsors
Funding source category [1] 257124 0
Government body
Name [1] 257124 0
National Health and Medical Research Council
Country [1] 257124 0
Australia
Primary sponsor type
Individual
Name
A/Professor Kim Donaghue
Address
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 256385 0
None
Name [1] 256385 0
Address [1] 256385 0
Country [1] 256385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259316 0
Women's and Children's Hospital Ethics Committee
Ethics committee address [1] 259316 0
Women's and Children's Hospital,
72 King street,
North adelaide,
SA 5006
Ethics committee country [1] 259316 0
Australia
Date submitted for ethics approval [1] 259316 0
17/11/2008
Approval date [1] 259316 0
10/12/2008
Ethics approval number [1] 259316 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31281 0
Address 31281 0
Country 31281 0
Phone 31281 0
Fax 31281 0
Email 31281 0
Contact person for public queries
Name 14528 0
Dr Barbara Sheil
Address 14528 0
Telethon Institute for Child Health,
100 Roberts Road, Subiaco,
Western Australia, 6008
Country 14528 0
Australia
Phone 14528 0
+61 8 9340 7858
Fax 14528 0
Email 14528 0
Barbara.Sheil@health.wa.gov.au
Contact person for scientific queries
Name 5456 0
Dr Barbara Sheil
Address 5456 0
Telethon Institute for Child Health,
100 Roberts Road, Subiaco,
Western Australia, 6008
Country 5456 0
Australia
Phone 5456 0
+61 8 9340 7858
Fax 5456 0
Email 5456 0
Barbara.Sheil@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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