Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

Phase 4

Completed

• Conditions: Postprandial Lipemia; Type 2 Diabetes
• Interventions: Drug: ezetimibe tablets; Drug: placebo; Drug: simvastatin tablets

• Registration Number: NCT00699023
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-03
• Last Update Posted: 2009-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo + simvastatin tablets 20 mg/die six weeks
1	simvastatin tablets	ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks
1	ezetimibe tablets	ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks
2	simvastatin tablets	placebo + simvastatin tablets 20 mg/die six weeks

Primary Outcome Measures

Name	Time	Method
Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions	6 weeks

Secondary Outcome Measures

Name	Time	Method
Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.	6 weeks
Postprandial LDL size	6 weeks
Fasting LDL concentration	6 weeks
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
Concentration and Composition of different lipoprotein subclasses in the fasting condition.	6 weeks

Trial Locations

Locations (1)

Department of Clinical and Experimental Medicine, Federico II University Hospital,; 🇮🇹 Naples, Italy