| Trial ID: | L2184 |
| Source ID: | NCT01581476
|
| Associated Drug: |
Statin
|
| Title: |
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
|
| Acronym: |
AdDIT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Statin|DRUG: ACE inhibitor|DRUG: Placebo|DRUG: Combination therapy
|
| Outcome Measures: |
Primary: Albumin creatinine ratio, The area under the curve over time of log ACR per year, with standardisation for gender, age and duration of disease, 2-4 years treatment duration | Secondary: Changes in CVD risk markers, 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., 2-4 yrs treatment duration|Changes in glomerular filtration rate (GFR), Changes in measures of GFR (plasma SDMA, creatinine adn cystatin C levels) assessed every 6 months during intervention period., 2-4 years treatment duration|Retinopathy, Changes in retinopathy scores and retinal microvascular structure (arteriolar or venular dilation, vascular fractile dimension, branching and tortuosity) assessed annually, 2-4 years treatment duration|Quality of Life and Health Economics, Changes in quality of life measures and resource usage, 2-4 years treatment duration
|
| Sponsor/Collaborators: |
Sponsor: University of Cambridge | 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
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE3
|
| Enrollment: |
443
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2009-01
|
| Completion Date: |
2017-06
|
| Results First Posted: |
|
| Last Update Posted: |
2018-06-28
|
| Locations: |
University of Western Australia, Perth, Australia|Hospital for Sick Children, Toronto, Ontario, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01581476
|
