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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin | Active Comparator | Simvastatin 20 mg/day |
|
| Rosuvastatin | Active Comparator | Rosuvastatin 20 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | 20 mg/day in one oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose tolerance assessed by HbA1c and fasting glucose | 1, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. | 1, 6, 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rome Tor Vergata | Rome | 00133 | Italy |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Rosuvastatin |
| Drug |
20 mg/day in one oral administration. |
|
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |