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
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
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
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
No
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
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