Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT01497912|
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : December 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Dyslipidemia||Drug: Atorvastatin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2010|
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
- Fibrin network permeability [ Time Frame: 8 weeks ]
- platelet and endothelial microparticles [ Time Frame: 8 weeks ]
- skin microvascular reactivity [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497912
|Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital|
|Stockholm, Sweden, 182 88|