Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT)
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|ClinicalTrials.gov Identifier: NCT01581476|
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Statin Drug: ACEI Drug: Placebo Drug: Combination therapy||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||443 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||June 2017|
Active Comparator: Statin
Participants receive active statin and placebo ACEI
10mg daily for a minimum period of 2 years
Other Name: Atorvastatin
Active Comparator: ACEI
Participants receive active ACEI and placebo statin
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
Placebo Comparator: Placebo
Participants receive placebo ACEI and placebo statin
Participants receive statin placebo and ACEI placebo
Participants receive both active ACEI and active Statin
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.
- Albumin creatinine ratio [ Time Frame: 2-4 years treatment duration ]The area under the curve over time of log ACR per year, with standardisation for gender, age and duration of disease
- Changes in CVD risk markers [ Time Frame: 2-4 yrs treatment duration ]
Changes in measures of:
- cIMT, FMD, EndoPAT and PWV between baseline and the end of intervention period;
- 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: 2-4 years treatment duration ]Changes in measures of GFR (plasma SDMA, creatinine adn cystatin C levels) assessed every 6 months during intervention period.
- Retinopathy [ Time Frame: 2-4 years treatment duration ]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: 2-4 years treatment duration ]Changes in quality of life measures and resource usage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581476
|University of Western Australia|
|Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||David B Dunger, Professor||University of Cambridge|