Clinical trial NCT00699023: Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes
Official title: Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postprandial Lipemia
Type 2 Diabetes
Keywords: postprandial lipemia
type 2 diabetes
ezetimibe
hypercholesterolemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2008-06-17
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions
timeFrame: 6 weeks
Secondary outcomes:
measure: Incremental AUC after a fat rich-meal of apo B48 concentration- marker of the number of intestinally derived lipoproteins- in chylomicron and VLDL
timeFrame: 6 weeks
measure: Fasting LDL concentration
timeFrame: 6 weeks
measure: Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.
timeFrame: 6 weeks
measure: Postprandial LDL size
timeFrame: 6 weeks
measure: Concentration and Composition of different lipoprotein subclasses in the fasting condition.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Clinical and Experimental Medicine, Federico II University Hospital,
Study officials:
affiliation: Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
name: Gabriele Riccardi, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.