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

NCT ID: NCT01497912

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Type 1 Diabetes Mellitus Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Atorvastatin

Atorvastatin 80mg once daily

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Atorvastatin 80mg once daily for 8 weeks

Placebo

Matched placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet once daily for 8 weeks

Interventions

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Atorvastatin

Atorvastatin 80mg once daily for 8 weeks

Intervention Type DRUG

Placebo

Placebo tablet once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Locations

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Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Related Links

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Other Identifiers

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Dnr 151:2004/52378

Identifier Type: OTHER

Identifier Source: secondary_id

Dnr 04-681/2

Identifier Type: -

Identifier Source: org_study_id