Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes
Patients with type 1 diabetes are at increased risk of vascular complications both in the micro- and macrocirculation. Hyperglycemia plays a major role in the development of these vascular complications, but other factors such increased platelet adhesion and aggregation, elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin generation, dyslipidemia and endothelial dysfunction may contribute.
Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and vasculature that are independent of their lipid-lowering properties.
The aim of the present study was to investigated the effects of intensive LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia. Furthermore, the effects of atorvastatin therapy on skin microvascular function was also investigated.
|Type 1 Diabetes Mellitus Dyslipidemia||Drug: Atorvastatin Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
- Fibrin network permeability [ Time Frame: 8 weeks ]
- platelet and endothelial microparticles [ Time Frame: 8 weeks ]
- skin microvascular reactivity [ Time Frame: 8 weeks ]
|Study Start Date:||January 2005|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Atorvastatin
Atorvastatin 80mg once daily
Atorvastatin 80mg once daily for 8 weeks
Placebo Comparator: Placebo
Matched placebo tablets
Placebo tablet once daily for 8 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497912
|Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital|
|Stockholm, Sweden, 182 88|