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The purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks |
|
| 2 | Placebo Comparator | placebo + simvastatin tablets 20 mg/die six weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe tablets | Drug | ezetimibe tablets 10 mg/die |
| |
| simvastatin tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental AUC after a fat rich-meal of apo B48 concentration- marker of the number of intestinally derived lipoproteins- in chylomicron and VLDL | 6 weeks | |
| Fasting LDL concentration | 6 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriele Riccardi, Prof | Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical and Experimental Medicine, Federico II University Hospital, | Naples | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15126535 | Background | Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9. doi: 10.1210/jc.2003-031764. | |
| 15458975 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
simvastatin tablets 20 mg/die |
|
| placebo | Drug | placebo |
|
| Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. |
| 6 weeks |
| Postprandial LDL size | 6 weeks |
| Concentration and Composition of different lipoprotein subclasses in the fasting condition. | 6 weeks |
| Annuzzi G, De Natale C, Iovine C, Patti L, Di Marino L, Coppola S, Del Prato S, Riccardi G, Rivellese AA. Insulin resistance is independently associated with postprandial alterations of triglyceride-rich lipoproteins in type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2004 Dec;24(12):2397-402. doi: 10.1161/01.ATV.0000146267.71816.30. Epub 2004 Sep 30. |
| 15243215 | Background | Davidson MH, Toth PP. Combination therapy in the management of complex dyslipidemias. Curr Opin Lipidol. 2004 Aug;15(4):423-31. doi: 10.1097/01.mol.0000137221.16160.b9. |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008148 |
| Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |