Back to results

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

Primary Purpose

Type 1 Diabetes Mellitus, Dyslipidemia

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Atorvastatin

Placebo

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

Atorvastatin 80mg once daily

Matched placebo tablets

Outcomes

Primary Outcome Measures

Fibrin network permeability

Secondary Outcome Measures

platelet and endothelial microparticles

skin microvascular reactivity

Full Information

NCT ID

NCT01497912

First Posted

December 22, 2011

Last Updated

December 22, 2011

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01497912

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2005

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus, Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin

Arm Type

Active Comparator

Arm Description

Atorvastatin 80mg once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matched placebo tablets

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Atorvastatin 80mg once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet once daily for 8 weeks

Primary Outcome Measure Information:

Title

Fibrin network permeability

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

platelet and endothelial microparticles

Time Frame

8 weeks

Title

skin microvascular reactivity

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

City

Stockholm

ZIP/Postal Code

182 88

Country

Sweden

12. IPD Sharing Statement

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/20637495

Description

PubMed

Learn more about this trial

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

We'll reach out to this number within 24 hrs