Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus Dyslipidemia |
Drug: Atorvastatin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
- Fibrin network permeability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- platelet and endothelial microparticles [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- skin microvascular reactivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | January 2005 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Atorvastatin
Atorvastatin 80mg once daily
|
Drug: Atorvastatin
Atorvastatin 80mg once daily for 8 weeks
|
|
Placebo Comparator: Placebo
Matched placebo tablets
|
Drug: Placebo
Placebo tablet once daily for 8 weeks
|
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01497912 History of Changes |
| Other Study ID Numbers: | Dnr 04-681/2, Dnr 151:2004/52378 |
| Study First Received: | December 22, 2011 |
| Last Updated: | December 22, 2011 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Dyslipidemias Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Lipid Metabolism Disorders Atorvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013