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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01497912
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : December 23, 2011
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Dyslipidemia Drug: Atorvastatin Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2005
Primary Completion Date : January 2009
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Fibrin network permeability [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. platelet and endothelial microparticles [ Time Frame: 8 weeks ]
  2. skin microvascular reactivity [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497912


Locations
Sweden
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Karolinska Institutet
More Information

Additional Information:
PubMed  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT01497912     History of Changes
Other Study ID Numbers: Dnr 04-681/2
Dnr 151:2004/52378 ( Other Identifier: Swedish Medical Products Agency )
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: January 2005

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 Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors