Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus; Dyslipidemia
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT01497912
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-01
• Study Start: 2005-01
• Primary Completion: 2009-01
• Study Completion: 2010-01
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-22
• Last Update Submitted: 2011-12-22
• Study First Posted: 2011-12-23
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• type 1 diabetes
• level of plasma LDL-cholesterol >2.5mmol/L and/or total cholesterol >4.5mmol/L

Exclusion Criteria

• History of macrovascular events

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched placebo tablets
Atorvastatin	Atorvastatin	Atorvastatin 80mg once daily

Primary Outcome Measures

Name	Time	Method
Fibrin network permeability	8 weeks

Secondary Outcome Measures

Name	Time	Method
platelet and endothelial microparticles	8 weeks
skin microvascular reactivity	8 weeks

Trial Locations

Locations (1)

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital; 🇸🇪 Stockholm, Sweden