| Trial ID: | L3195 |
| Source ID: | NCT01236365
|
| Associated Drug: |
Atorvastatin
|
| Title: |
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01236365/results
|
| Conditions: |
Diabetes Mellitus, Insulin-Dependent|Hypercholesterolemia
|
| Interventions: |
DRUG: Atorvastatin|DRUG: Atorvastatin Placebo
|
| Outcome Measures: |
Primary: LDL-C Levels Assessed at Randomization and 6 Months, To assess if the use of statins in children with type 1 DM is safe, improves measures of LDL-C. Subjects will have a physical exam, laboratories, nutritional counseling and moderate aerobic exercise recommended. Diabetes management will be intensified. At 3 months fasting lipoprotein fractions (ion mobility)re-drawn and if LDL-C \>100mg/dl patients will be randomized to treatment with statins or placebo for 6 months, randomization stratified by BP and microalbuminuria, duration of diabetes and HgA1C. At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline., Randomization and 6 months|Hs-CRP Levels Assessed at Randomization and 6 Months, To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers., Randomization and 6 months | Secondary: MAGE, Mean amplitude of glycemic excursion (MAGE) with continuous glucose monitoring (CGM - IPro®, Medtronic Minimed) worn blindly for 6d to assess glucose variability, Randomization and 6 months|RAGE, Receptor for Advanced Glycation End Products, Randomization and 6 months|Descending Aortic Strain, Subclinical atherosclerosis and arterial stiffness of abdominal aortic MRI, Randomization
|
| Sponsor/Collaborators: |
Sponsor: Nemours Children's Clinic | Collaborators: Pfizer|Medtronic|Quest Diagnostics-Nichols Insitute
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-10
|
| Completion Date: |
2014-11
|
| Results First Posted: |
2015-05-21
|
| Last Update Posted: |
2019-06-25
|
| Locations: |
Alfred I duPont Hospital, Wilmington, Delaware, United States|Nemours Children's Clinic, Jacksonville, Florida, 32207, United States|Nemours Children's Clinic, Orlando, Florida, United States|Nemours Children's Clinic, Pensacola, Florida, 32504, United States|Nemours Children's Clinic-Jefferson, Philadelphia, Pennsylvania, 19107, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01236365
|
