Dyslipidemia, Type 1 Diabetes Mellitus
Conditions
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.
Interventions
DRUGAtorvastatin
Atorvastatin 80mg once daily for 8 weeks
DRUGPlacebo
Placebo tablet once daily for 8 weeks
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fibrin network permeability | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| platelet and endothelial microparticles | 8 weeks |
| skin microvascular reactivity | 8 weeks |
Countries
Sweden
Outcome results
None listed