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ISRCTN
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ISRCTN91419926
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ClinicalTrials.gov identifier
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Public title
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Adolescent type 1 diabetes cardio-renal intervention trial
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Scientific title
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Acronym
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Adolescent Diabetes Intervention Trial (AdDIT)
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Serial number at source
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RP06
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Study hypothesis
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To determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), statins, or a combination of both, when compared with placebo, will:
1. Reduce albumin excretion as assessed by six monthly measurement of Albumin/Creatinine Ratio (ACR) in three early morning urines
2. Reduce the incidence of Microalbuminuria (MA) (ACR log mean greater than 3.5 mg/mmol (males) or greater than 4 mg/mmol [females] in two out of three urines) at the end of the study period
3. Reduce the incidence of MA during the six month run out period following the completion of intervention phase
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Lay summary
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Ethics approval
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Ethics approval received from the South West Research Ethics Committee on the 6th March 2008 (ref: 08/HO206/4).
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Study design
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Randomised controlled double blind clinical trial
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Countries of recruitment
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Australia, Canada, United Kingdom
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Disease/condition/study domain
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Type 1 diabetes
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Participants - inclusion criteria
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1. Type 1 diabetes diagnosed for greater than one year
2. Aged 11 to 15 years
3. High risk for the development of diabetic nephropathy and Cardiovascular Disease (CVD) as predicted by albumin excretion in the upper tertile after appropriate adjustment for age, sex, age at diagnosis and duration of disease
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Participants - exclusion criteria
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1. Non-type 1 diabetes, 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 diabetic nephropathy
3. Pregnancy, or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial
4. Severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia
5. Established hypertension unrelated to diabetic nephropathy
6. Prior exposure to the investigational products, statins and ACEI
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Anticipated start date
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01/08/2008
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Anticipated end date
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31/12/2012
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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500
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Interventions
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Please note that as of 30/04/08 this trial is is set-up and the anticipated start date of this trial has been changed. The previous anticipated start date of this trial was 01/01/2008.
Four arm randomisation:
1. Quinapril, 5 - 10 mg daily and placebo
2. Atorvostatin, 10 mg daily and placebo
3. Quinapril and atorvostatin
4. Placebo
The duration of study will be three to four years, that is until subjects reach the age of 14 to 18 years and they will also be studied for an additional six months during the run out period.
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Primary outcome measure(s)
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The primary endpoint is defined as the area under the curve over time of log albumin-creatinine ratio per year, with standardisation for gender, age and duration of disease.
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Secondary outcome measure(s)
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1. Changes in carotid intimal media thickness, between baseline and the end of intervention period
2. Changes in arterial Blood Pressure (BP), lipids and other lipoproteins, CVD risk markers (high-sensitive C-Reactive Protein [hsCRP] and Asymmetric Dimethylarginine [ADMA]), assessed every six months during the intervention period
3. Changes in measures of Glomerular Filtration Rate (GFR) (plasma Symmetrical Dimethylarginine [SDMA], creatinine and cystatin C) assessed every six months during the intervention period
4. Changes in quality of life and health economics
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Sources of funding
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1. Diabetes UK (UK) (ref: RD06/0003341)
2. Juvenile Diabetes Research Foundation (UK) (ref: 8-2007-902)
3. British Heart Foundation (UK) (ref: SP/07/002/23394)
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Trial website
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Publications
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2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20017932
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Contact name
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Prof
David
Dunger
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Address
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University Department of Paediatrics
Box 116, Addenbrooke's Hospital
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City/town
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Cambridge
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Zip/Postcode
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CB2 0QQ
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Country
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United Kingdom
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Email
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dbd25@cam.ac.uk
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Sponsor
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University of Cambridge and Cambridge University Hospitals NHS Foundation Trust (UK)
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Address
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Research Service Division
16 Mill Lane
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City/town
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Cambridge
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Zip/Postcode
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CB2 1SB
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Country
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United Kingdom
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Email
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helen.atkinson@rsd.cam.ac.uk
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Sponsor website:
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http://www.cam.ac.uk/
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Date applied
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30/07/2007
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Last edited
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16/04/2010
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Date ISRCTN assigned
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03/10/2007
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