Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

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NCT01581476

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Study Location
University of Western Australia
Perth, , , Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-16 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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NCT01581476
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Advanced Information
Descriptive Information
Brief Title  ICMJE Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
Official Title  ICMJE 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
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.
Detailed Description

Subjects will be recruited from a pre-screened population of 3,000 young people with T1D aged 10 to 16 years based on assessment of risk for future CVD and DN.

They will be randomised to a 2 x 2 factorial design contrasting the effects of ACEI, statins, or combination therapy to placebo over a maximum four year treatment period. Minimisation of variation in albumin excretion rate, gender, age, diabetes duration, HbA1c, total cholesterol and centre site will be undertaken at randomisation.

Analysis of the primary endpoint, change in albumin excretion will be undertaken on an intention to treat basis. Secondary analyses will be undertaken on the basis of 'as treated' allowing for variance in compliance and allowing for subjects who show substantial change in HbA1c levels. Additional analyses will be undertaken to assess changes in the secondary objectives and to assess the overall effect of the intervention on quality of life and health economics.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Statin
    Participants receive active statin and placebo ACE Inhibitor
    Intervention: Drug: Statin
  • Active Comparator: Angiotensin-converting enzyme inhibitor
    Participants receive active ACE Inhibitor and placebo statin
    Intervention: Drug: ACE inhibitor
  • Placebo Comparator: Placebo
    Participants receive placebo ACE Inhibitor and placebo statin
    Intervention: Drug: Placebo
  • Combination therapy
    Participants receive both active ACE Inhibitor and active Statin
    Intervention: Drug: Combination therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2017)		443
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)		500
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01581476
Other Study ID Numbers  ICMJE RP06
2007-001039-72 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Dunger, University of Cambridge
Study Sponsor  ICMJE University of Cambridge
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator:David B Dunger, ProfessorUniversity of Cambridge
PRS Account University of Cambridge
Verification Date June 2018

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