Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

Phase 3

Completed

• Conditions: Type 2 Diabetes; Diabetic Dyslipidemia
• Interventions: Drug: Simvastatin; Drug: Rosuvastatin

• Registration Number: NCT00854503
• Lead Sponsor: University of Rome Tor Vergata

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Primary Completion: 2010-03
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Type 2 diabetes in good glycemic control, treated with metformin alone.
• Untreated dyslipidemia.
• BMI <30.

Exclusion Criteria

• History of cancer.
• History of cardiovascular diseases.
• Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin	Simvastatin 20 mg/day
Rosuvastatin	Rosuvastatin	Rosuvastatin 20 mg/day

Primary Outcome Measures

Name	Time	Method
Glucose tolerance assessed by HbA1c and fasting glucose	1, 6, 12 months

Secondary Outcome Measures

Name	Time	Method
insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.	1, 6, 12 months.

Trial Locations

Locations (1)

University of Rome Tor Vergata; 🇮🇹 Rome, Italy