Effects of ezetimibe in association with statins on postprandial lipemia in type 2 diabetic patients - Ezetimibe effects on postprandial lipemia

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: SOCClassification code 10027433; MedDRA version: 9.1Level: HLGTClassification code 10013317; MedDRA version: 9.1Level: PTClassification code 10062060; MedDRA version: 9.1Level: LLTClassification code 10020661

• Registration Number: EUCTR2008-000824-20-IT
• Lead Sponsor: IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-25
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aims of this protocol are to evaluate the effects of ezetimibe - in association with a statin vs. a statin alone - on postprandial lipemia, in particular on the number and composition of either intestinally derived and hepatic derived lipoprotein particles, in type 2 diabetic patients.;Secondary Objective: to evaluate the effects of ezetimibe - in association with a statin vs. a statin alone - on: - Fasting LDL cholesterol concentration. - Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. - Postprandial LDL size. - Concentration and Composition of different lipoprotein subclasses in the fasting condition.;Primary end point(s): Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions.