NCT01581476

Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2012-04-20
• Last updated: 2018-06-28

Locations

2 sites across 2 countries: Australia, Canada