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

This study is currently recruiting participants.
Verified January 2013 by Cambridge University Hospitals NHS Foundation Trust
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: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
 Drug: Statin
Drug: Ace Inhibitor
Drug: Placebo
Drug: Combination therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Statin
Participants receive active statin and placebo ACEI
 Drug: Statin
10mg daily for a minimum period of 3 years
Other Name: Atorvastatin
Active Comparator: ACEI
Participants receive active ACEI and placebo statin
 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 3 years.
Other Name: Quinapril
Placebo Comparator: Placebo
Participants receive placebo ACEI and placebo statin
 Drug: Placebo
Participants receive statin placebo and ACEI placebo
Combination therapy
Participants receive both active ACEI and active Statin
 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 3 years.
Other Names:
  • Atorvastatin
  • Quinapril

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581476

Contacts
Contact: Stella K Silvester +44(0) 1223 762944 sks28@medschl.cam.ac.uk
Contact: Tracey J Stevens +44(0) 1223 768613 tjs64@medschl.cam.ac.uk

Locations
Australia
University of Western Australia Recruiting
Perth, Australia
Contact: Barbara Sheil, PhD     +61 893 407858     barbara.sheil@health.wa.gov.au    
Principal Investigator: Timothy Jones, Professor            
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Yesmino Elia, Msc     416 813 7654 ext 1518     yesmino.elia@sickkids.ca    
Principal Investigator: Denis Daneman, Professor            
Sponsors and Collaborators
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
Investigators
Principal Investigator: David B Dunger, Professor University of Cambridge
  More Information

Additional Information:
Click here for information about the Adolescent Type 1 Diabetes Cardio Renal Intervention Trial (AdDIT)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: David B Dunger, Professor David Dunger, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01581476     History of Changes
Other Study ID Numbers: RP06, 2007-001039-72
Study First Received: April 13, 2012
Last Updated: January 22, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Adolescence

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Quinapril
Enzyme Inhibitors
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 19, 2013