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

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Karolinska Institute

Status and phase

Completed
Phase 4

Conditions

Type 1 Diabetes Mellitus
Dyslipidemia

Treatments

Drug: Placebo
Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01497912
Dnr 04-681/2
Dnr 151:2004/52378 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Atorvastatin
Active Comparator group
Description:
Atorvastatin 80mg once daily
Treatment:
Drug: Atorvastatin
Placebo
Placebo Comparator group
Description:
Matched placebo tablets
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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