Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

NCT ID: NCT00854503

Last Updated: 2011-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Diabetic Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Simvastatin

Simvastatin 20 mg/day

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

20 mg/day in one oral administration

Rosuvastatin

Rosuvastatin 20 mg/day

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

20 mg/day in one oral administration.

Interventions

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Simvastatin

20 mg/day in one oral administration

Intervention Type DRUG

Rosuvastatin

20 mg/day in one oral administration.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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University of Rome Tor Vergata

Locations

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University of Rome Tor Vergata

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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131/08

Identifier Type: -

Identifier Source: org_study_id

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