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Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Diabetes UK
British Heart Foundation
Pfizer
The University of Western Australia
The Hospital for Sick Children
University of Oxford
St Thomas' Hospital, London
Information provided by (Responsible Party):
David B Dunger, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01581476
First received: April 13, 2012
Last updated: May 22, 2014
Last verified: December 2013

April 13, 2012
May 22, 2014
January 2009
December 2015   (final data collection date for primary outcome measure)
Albumin creatinine ratio [ Time Frame: 2-4 years treatment duration ] [ Designated as safety issue: No ]
The area under the curve over time of log ACR per year, with standardisation for gender, age and duration of disease
Albumin creatinine ratio [ Time Frame: 3-4 years treatment duration ] [ Designated as safety issue: No ]
The area under the curve over time of log ACR per year, with standardisation for gender, age and duration of disease
Complete list of historical versions of study NCT01581476 on ClinicalTrials.gov Archive Site
  • Changes in CVD risk markers [ Time Frame: 2-4 yrs treatment duration ] [ Designated as safety issue: No ]

    Changes in measures of:

    1. cIMT, FMD, EndoPAT and PWV between baseline and the end of intervention period;
    2. arterial BP, lipids and other lipoproteins, CVD risk markers (hsCRP and ADMA), assessed every 6 months during the intervention period.
  • Changes in glomerular filtration rate (GFR) [ Time Frame: 2-4 years treatment duration ] [ Designated as safety issue: No ]
    Changes in measures of GFR (plasma SDMA, creatinine adn cystatin C levels) assessed every 6 months during intervention period.
  • Retinopathy [ Time Frame: 2-4 years treatment duration ] [ Designated as safety issue: No ]
    Changes in retinopathy scores and retinal microvascular structure (arteriolar or venular dilation, vascular fractile dimension, branching and tortuosity) assessed annually
  • Quality of Life and Health Economics [ Time Frame: 2-4 years treatment duration ] [ Designated as safety issue: No ]
    Changes in quality of life measures and resource usage
  • Changes in CVD risk markers [ Time Frame: 3-4 yrs treatment duration ] [ Designated as safety issue: No ]

    Changes in measures of:

    1. cIMT, FMD, EndoPAT and PWV between baseline and the end of intervention period;
    2. arterial BP, lipids and other lipoproteins, CVD risk markers (hsCRP and ADMA), assessed every 6 months during the intervention period.
  • Changes in glomerular filtration rate (GFR) [ Time Frame: 3-4 years treatment duration ] [ Designated as safety issue: No ]
    Changes in measures of GFR (plasma SDMA, creatinine adn cystatin C levels) assessed every 6 months during intervention period.
  • Retinopathy [ Time Frame: 3-4 years treatment duration ] [ Designated as safety issue: No ]
    Changes in retinopathy scores and retinal microvascular structure (arteriolar or venular dilation, vascular fractile dimension, branching and tortuosity) assessed annually
  • Quality of Life and Health Economics [ Time Frame: 3-4 yeasr treatment duration ] [ Designated as safety issue: No ]
    Changes in quality of life measures and resource usage
Not Provided
Not Provided
 
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Type 1 Diabetes
  • Drug: Statin
    10mg daily for a minimum period of 2 years
    Other Name: Atorvastatin
  • Drug: 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.
    Other Name: Quinapril
  • Drug: Placebo
    Participants receive statin placebo and ACEI placebo
  • Drug: 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.
    Other Names:
    • Atorvastatin
    • Quinapril
  • Active Comparator: Statin
    Participants receive active statin and placebo ACEI
    Intervention: Drug: Statin
  • Active Comparator: ACEI
    Participants receive active ACEI and placebo statin
    Intervention: Drug: Ace Inhibitor
  • Placebo Comparator: Placebo
    Participants receive placebo ACEI and placebo statin
    Intervention: Drug: Placebo
  • Combination therapy
    Participants receive both active ACEI and active Statin
    Intervention: Drug: Combination therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
June 2016
December 2015   (final data collection date for primary outcome measure)

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.

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.
Both
10 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada
 
NCT01581476
RP06, 2007-001039-72
Yes
David B Dunger, Cambridge University Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
  • Juvenile Diabetes Research Foundation
  • Diabetes UK
  • British Heart Foundation
  • Pfizer
  • The University of Western Australia
  • The Hospital for Sick Children
  • University of Oxford
  • St Thomas' Hospital, London
Principal Investigator: David B Dunger, Professor University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP