Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

Condition(s) targeted: Postprandial Lipemia; Type 2 Diabetes

Intervention: ezetimibe tablets (Drug); simvastatin tablets (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Federico II University

Official(s) and/or principal investigator(s):
Gabriele Riccardi, Prof, Study Chair, Affiliation: Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy

Overall contact:
Angela A Rivellese, Prof, Phone: 39-081-746-2154, Email: rivelles@unina.it

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.

Official title: Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study

Primary outcome: incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions

Secondary outcome:

incremental AUC after a fat rich-meal of apo B48 concentration- marker of the number of intestinally derived lipoproteins- in chylomicron and VLDL

fasting LDL concentration

Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.

Postprandial LDL size.

Concentration and Composition of different lipoprotein subclasses in the fasting condition.

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes since at least two years

- Stable metabolic control (HbA1c<8. 0%) for at least six months on diet or diet+oral

hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.

- BMI<30 kg/m2 and body weight stable during the last six months.

- Both sexes; only post-menopausal women.

- LDL-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.

- No use of hypolipidemic drugs in the last three months.

Exclusion Criteria:

- Patient with renal (serum creatinine >1. 5 mg/dl) or hepatic (serum transaminases

>three times upper normal values) impairment.

- Patients with history of cardiovascular disease.

- Pre-menopausal women.

- Any other acute or chronic degenerative disease.

- Anemia (Hb<12 g/dl).

- Uncontrolled blood pressure.

- Use of any drugs able to interfere with the study medications

Angela A Rivellese, Prof, Phone: 39-081-746-2154, Email: rivelles@unina.it

Department of Clinical and Experimental Medicine, Federico II University Hospital,, Naples 80131, Italy; Recruiting
Angela A Rivellese, Prof., Principal Investigator

Related publications:

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.

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. Epub 2004 Sep 30.

Davidson MH, Toth PP. Combination therapy in the management of complex dyslipidemias. Curr Opin Lipidol. 2004 Aug;15(4):423-31. Review.

Starting date: June 2008
Ending date: December 2009
Last updated: January 28, 2009