NCT00854503

Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.

Conditions

• Type 2 Diabetes
• Diabetic Dyslipidemia

Interventions

Type	Name	Description
DRUG	Simvastatin	20 mg/day in one oral administration
DRUG	Rosuvastatin	20 mg/day in one oral administration.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-03-01
• Completion: 2010-12-01
• First posted: 2009-03-03
• Last updated: 2011-05-12

Locations

1 site across 1 country: Italy