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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01581476
Registration number
NCT01581476
Ethics application status
Date submitted
13/04/2012
Date registered
20/04/2012
Date last updated
28/06/2018
Titles & IDs
Public title
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
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Scientific title
Randomised, Double Blind, Placebo Controlled Trial of Angiotensin Converting Enzyme Inhibitors and Statins in the Prevention of Long Term Complications in Young People With Type 1 Diabetes
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Secondary ID [1]
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2007-001039-72
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Secondary ID [2]
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RP06
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Universal Trial Number (UTN)
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Trial acronym
AdDIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Statin
Treatment: Drugs - ACE inhibitor
Treatment: Drugs - Placebo
Treatment: Drugs - Combination therapy
Active Comparator: Statin - Participants receive active statin and placebo ACE Inhibitor
Active Comparator: Angiotensin-converting enzyme inhibitor - Participants receive active ACE Inhibitor and placebo statin
Placebo Comparator: Placebo - Participants receive placebo ACE Inhibitor and placebo statin
Other: Combination therapy - Participants receive both active ACE Inhibitor and active Statin
Treatment: Drugs: Statin
10mg daily for a minimum period of 2 years
Treatment: Drugs: ACE inhibitor
Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.
Treatment: Drugs: Placebo
Participants receive statin placebo and ACEI placebo
Treatment: Drugs: Combination therapy
Participants receive both active statin and active ACEI. Dose for Statins is 10mg daily. Dosing for ACEI starts at 5mg daily rising to 10mg after 14 days providing it is well tolerated. Both interventions last for a minimum of 2 years.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Albumin creatinine ratio
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Assessment method [1]
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The area under the curve over time of log ACR per year, with standardisation for gender, age and duration of disease
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Timepoint [1]
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2-4 years treatment duration
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Secondary outcome [1]
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Changes in CVD risk markers
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Assessment method [1]
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Changes in measures of:
cIMT, FMD, EndoPAT and PWV between baseline and the end of intervention period;
arterial BP, lipids and other lipoproteins, CVD risk markers (hsCRP and ADMA), assessed every 6 months during the intervention period.
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Timepoint [1]
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2-4 yrs treatment duration
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Secondary outcome [2]
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Changes in glomerular filtration rate (GFR)
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Assessment method [2]
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Changes in measures of GFR (plasma SDMA, creatinine adn cystatin C levels) assessed every 6 months during intervention period.
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Timepoint [2]
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2-4 years treatment duration
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Secondary outcome [3]
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Retinopathy
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Assessment method [3]
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Changes in retinopathy scores and retinal microvascular structure (arteriolar or venular dilation, vascular fractile dimension, branching and tortuosity) assessed annually
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Timepoint [3]
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2-4 years treatment duration
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Secondary outcome [4]
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Quality of Life and Health Economics
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Assessment method [4]
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Changes in quality of life measures and resource usage
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Timepoint [4]
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2-4 years treatment duration
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Eligibility
Key inclusion criteria
1. Age 10 to 16 years.
2. T1D diagnosed for more than 1 year or C-peptide negative.
3. Centralised assessment of ACR based on six early morning urines deemed to be in upper
tertile for risk after adjustment for age, gender, age at diagnosis and duration of
disease.
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Minimum age
10
Years
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Maximum age
16
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Non T1D, i.e. type 2 diabetes, insulin dependent diabetes related to monogenic
disease, secondary diabetes.
2. ACR based on six early morning urines deemed to be at low risk for subsequent
development of CVD or DN.
3. Pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy
testing throughout the trial.
4. Breast feeding
5. Severe hyperlipidaemia and family history data to support diagnosis of familial
hypercholesterolaemia.
6. Established hypertension unrelated to DN.
7. Prior exposure to the investigational products, statins and ACEI.
8. Unwillingness/inability to comply with the study protocol.
9. Other co-morbidities considered unsuitable by the investigator (excluding treated
hypothyroidism and coeliac disease).
10. Proliferative retinopathy.
11. Renal disease not associated with Type 1 Diabetes.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2017
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Sample size
Target
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Accrual to date
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Final
443
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University of Western Australia - Perth
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Recruitment postcode(s) [1]
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- Perth
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Cambridge
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Juvenile Diabetes Research Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Diabetes UK
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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British Heart Foundation
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Address [3]
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Country [3]
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Other collaborator category [4]
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Commercial sector/Industry
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Name [4]
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Pfizer
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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The University of Western Australia
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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The Hospital for Sick Children
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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University of Oxford
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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St Thomas' Hospital, London
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Address [8]
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Country [8]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether use of blood pressure lowering drugs,
Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs
(statins) may have a place in the treatment of adolescents with diabetes and can help reduce
serious long-term health problems in this population.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01581476
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Trial related presentations / publications
Amin R, Widmer B, Prevost AT, Schwarze P, Cooper J, Edge J, Marcovecchio L, Neil A, Dalton RN, Dunger DB. Risk of microalbuminuria and progression to macroalbuminuria in a cohort with childhood onset type 1 diabetes: prospective observational study. BMJ. 2008 Mar 29;336(7646):697-701. doi: 10.1136/bmj.39478.378241.BE. Epub 2008 Mar 18.
Dunger DB, Schwarze CP, Cooper JD, Widmer B, Neil HA, Shield J, Edge JA, Jones TW, Daneman D, Dalton RN. Can we identify adolescents at high risk for nephropathy before the development of microalbuminuria? Diabet Med. 2007 Feb;24(2):131-6. doi: 10.1111/j.1464-5491.2006.02047.x.
Adolescent type 1 Diabetes cardio-renal Intervention Trial Research Group. Adolescent type 1 Diabetes Cardio-renal Intervention Trial (AdDIT). BMC Pediatr. 2009 Dec 17;9:79. doi: 10.1186/1471-2431-9-79.
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Public notes
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Contacts
Principal investigator
Name
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David B Dunger, Professor
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Address
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University of Cambridge
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01581476
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