Overview

Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Cambridge
Collaborators:
British Heart Foundation
Diabetes UK
Juvenile Diabetes Research Foundation
Pfizer
St Thomas' Hospital, London
The Hospital for Sick Children
The University of Western Australia
University of Oxford
Treatments:
Angiotensin-Converting Enzyme Inhibitors
Atorvastatin
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Quinapril
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.