ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline and annually for 4 years

Secondary outcome [1]

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]

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?

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]

6008

Recruitment postcode(s) [2]

3052

Recruitment postcode(s) [3]

5006

Recruitment postcode(s) [4]

2145

Recruitment postcode(s) [5]

4101

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Hospital Ethics Committee

Ethics committee address [1]

Women's and Children's Hospital,
72 King street,
North adelaide,
SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/11/2008

Approval date [1]

10/12/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Barbara Sheil

Address

Telethon Institute for Child Health,
100 Roberts Road, Subiaco,
Western Australia, 6008

Country

Australia

Phone

+61 8 9340 7858

Fax

Barbara.Sheil@health.wa.gov.au

Contact person for scientific queries

Name

Dr Barbara Sheil

Address

Telethon Institute for Child Health,
100 Roberts Road, Subiaco,
Western Australia, 6008

Country

Australia

Phone

+61 8 9340 7858

Fax

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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