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

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01497912
First received: December 22, 2011
Last updated: NA
Last verified: January 2005
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Fibrin network permeability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014