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

Tracking Information

First Received Date ^ICMJE

April 13, 2012

Last Updated Date

January 22, 2013

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01581476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Type 1 Diabetes

Intervention ^ICMJE

Drug: Statin
10mg daily for a minimum period of 3 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 3 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 3 years.
Other Names:
- Atorvastatin
- Quinapril

Study Arm (s)

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

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

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

June 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 10 to 16 years.
T1D diagnosed for more than 1 year or C-peptide negative.
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:

Non T1D, i.e. type 2 diabetes, insulin dependent diabetes related to monogenic disease, secondary diabetes.
ACR based on six early morning urines deemed to be at low risk for subsequent development of CVD or DN.
Pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial.
Breast feeding
Severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia.
Established hypertension unrelated to DN.
Prior exposure to the investigational products, statins and ACEI.
Unwillingness/inability to comply with the study protocol.
Other co-morbidities considered unsuitable by the investigator (excluding treated hypothyroidism and coeliac disease).
Proliferative retinopathy.
Renal disease not associated with Type 1 Diabetes.

Gender

Both

Ages

10 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Australia, Canada

Administrative Information

NCT Number ^ICMJE

NCT01581476

Other Study ID Numbers ^ICMJE

RP06, 2007-001039-72

Has Data Monitoring Committee

Yes

Responsible Party

David B Dunger, Cambridge University Hospitals NHS Foundation Trust

Study Sponsor ^ICMJE

Cambridge University Hospitals NHS Foundation Trust

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, Professor

University of Cambridge

Information Provided By

Cambridge University Hospitals NHS Foundation Trust

Verification Date

January 2013

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

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