Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854503
• Other study ID #: 131/08
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2009
• Last updated: May 11, 2011
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Dyslipidemia
• Dyslipidemias
• Type 2 Diabetes

Intervention

Drug:
• Simvastatin
20 mg/day in one oral administration
• Rosuvastatin
20 mg/day in one oral administration.

Locations

Country	Name	City	State
Italy	University of Rome Tor Vergata	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance assessed by HbA1c and fasting glucose		1, 6, 12 months	No
Secondary	insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.		1, 6, 12 months.	No