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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT01497912
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 0.3

Study Details

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
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2010

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 [8 weeks]

Secondary Outcome Measures

1. platelet and endothelial microparticles [8 weeks]

2. skin microvascular reactivity [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital	Stockholm		Sweden	182 88

Sponsors and Collaborators

• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• PubMed

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01497912
• Other Study ID Numbers: Dnr 04-681/2; Dnr 151:2004/52378
• First Posted: Dec 23, 2011
• Last Update Posted: Dec 23, 2011
• Last Verified: Jan 1, 2005

• Additional relevant MeSH terms: Diabetes Mellitus, Type 1; Dyslipidemias; Atorvastatin

Study Results

No Results Posted as of Dec 23, 2011