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

NCT01497912 | Completed Phase 4 DMC

• 2 other identifiers: Dnr 04-681/2Dnr 151:2004/52378
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Fibrin network permeability

  8 weeks

Secondary Outcomes (2)

• platelet and endothelial microparticles

  8 weeks

• skin microvascular reactivity

  8 weeks

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 80mg once daily

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Matched placebo tablets

Drug: Placebo

Interventions

Atorvastatin DRUG

Atorvastatin 80mg once daily for 8 weeks

Atorvastatin

Placebo DRUG

Placebo tablet once daily for 8 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 1 diabetes
• level of plasma LDL-cholesterol \>2.5mmol/L and/or total cholesterol \>4.5mmol/L

You may not qualify if:

• History of macrovascular events

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Stockholm, 182 88, Sweden

Location

Related Links

• PubMed

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 23, 2011

Record last verified: 2005-01

Locations

SE (1)