Vasoprotection by Atorvastatin in Children and Adolescents with Diabetes Type 1, a 2-Year Pilot Study

Phase 3

• Conditions: E10; Type 1 diabetes mellitus

• Registration Number: DRKS00000297
• Lead Sponsor: Zentrum für Kinder- und JugendmedizinUniversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-11
• Study Completion: 2010-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Diabetes type 1
- LDL-C below 130 mg/dL
- Increased IMT above 0.53 mm
- Male or female
- CPK below 217 I

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Reduction of Endothelial- / inflammation markers, lipoprotein-associated phospholipase A2 , PAI-1 <br>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)