Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

University of Rome Tor Vergata

Status and phase: Completed; Phase 3

Conditions: Diabetic Dyslipidemia; Type 2 Diabetes

Treatments: Drug: Rosuvastatin; Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00854503

131/08

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Simvastatin

Active Comparator group

Description:

Simvastatin 20 mg/day

Treatment:

Drug: Simvastatin

Rosuvastatin

Active Comparator group

Description:

Rosuvastatin 20 mg/day

Treatment:

Drug: Rosuvastatin