Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

• Sponsor: University of Rome Tor Vergata (Other)
• Overall Status: Completed
• CT.gov ID: NCT00854503
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Diabetic Dyslipidemia	Drug: Simvastatin; Drug: Rosuvastatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Simvastatin Simvastatin 20 mg/day	Drug: Simvastatin; 20 mg/day in one oral administration
Active Comparator: Rosuvastatin Rosuvastatin 20 mg/day	Drug: Rosuvastatin; 20 mg/day in one oral administration.

Outcome Measures

Primary Outcome Measures

1. Glucose tolerance assessed by HbA1c and fasting glucose [1, 6, 12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rome Tor Vergata	Rome		Italy	00133

Sponsors and Collaborators

• University of Rome Tor Vergata

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00854503
• Other Study ID Numbers: 131/08
• First Posted: Mar 3, 2009
• Last Update Posted: May 12, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Statins administration in diabetic dyslipidemia
• Additional relevant MeSH terms: Dyslipidemias; Rosuvastatin Calcium; Simvastatin

Study Results

No Results Posted as of May 12, 2011