Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

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.

Conditions

• Type 1 Diabetes

Interventions

DRUG

Statin

10mg daily for a minimum period of 2 years

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.

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.

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Diabetes UK

  collaborator OTHER

• British Heart Foundation

  collaborator OTHER

• Pfizer

  collaborator INDUSTRY

• The University of Western Australia

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• St Thomas' Hospital, London

  collaborator OTHER

• University of Cambridge

  lead OTHER

Principal Investigators

• David B Dunger, Professor · University of Cambridge

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

10 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2017-04-30

Completion

2017-06-30

Countries

• Australia
• Canada

Study Locations