E10
Conditions
Interventions
Group 1: 10 mg/day atorvastatin per oral over 24 months
Group 2: Placebo
Sponsors
Zentrum für Kinder- und Jugendmedizin
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
10 Years to 20 Years
Inclusion criteria
Inclusion criteria: - Diabetes type 1 - LDL-C below 130 mg/dL - Increased IMT above 0.53 mm - Male or female - CPK below 217 IU
Exclusion criteria
Exclusion criteria: - Pregnancy or breastfeeding - Active liver disease or hepatic dysfunction, AST or ALT above 3x the upper limit of normal (ULN) - CPK above 5xULN or above 3xULN with muscle pain, tenderness, or weakness - Severe renal dysfunction, nephrotic syndrome - Known hypersensitivity to HMG-CoA reductase inhibitors - Other significant abnormalities that may compromise the patient`s safety or successful participation in the study - LDL-C below 25 mg/dL and above 130 mg/dL during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regression of Intima media thickness / roughness of the carotic arteries by B-mode ultra- sound in children with type 1 diabetes mellitus after 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction of Endothelial- / inflammation markers, lipoprotein-associated phospholipase A2 , PAI-1 2. Percent change from baseline in total cholesterol (TC), triglycerides (TG), LDL-C, HDL-C, VLDL-C, Apo AI, Apo AII, apo B, Lp(a) | — |
Countries
Germany
Contacts
Public ContactAndreas Krebs
Zentrum für Kinder- und Jugendmedizin Universitätsklinikum Freiburg
Outcome results
None listed