Skip to main content
OpenTrials
Completed

NCT Number: NCT00699023

Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postprandial Lipemia Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical and Experimental Medicine, Federico II University Hospital,

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe tablets

Drug

ezetimibe tablets 10 mg/die

Simvastatin tablets

Drug

simvastatin tablets 20 mg/die

Placebo

Drug

placebo

Primary outcomes

  1. Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

  2. Fasting LDL concentration

    Time frame: 6 weeks

  3. Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.

    Time frame: 6 weeks

  4. Postprandial LDL size

    Time frame: 6 weeks

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

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: EZE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Nov 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.