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Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes (EZE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699023
First Posted: June 17, 2008
Last Update Posted: November 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federico II University
  Purpose
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.

Condition Intervention Phase
Postprandial Lipemia Type 2 Diabetes Drug: ezetimibe tablets Drug: simvastatin tablets Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • 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 ]
  • Fasting LDL concentration [ Time Frame: 6 weeks ]
  • Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. [ Time Frame: 6 weeks ]
  • Postprandial LDL size [ Time Frame: 6 weeks ]
  • Concentration and Composition of different lipoprotein subclasses in the fasting condition. [ Time Frame: 6 weeks ]

Estimated Enrollment: 13
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks
Drug: ezetimibe tablets
ezetimibe tablets 10 mg/die
Drug: simvastatin tablets
simvastatin tablets 20 mg/die
Placebo Comparator: 2
placebo + simvastatin tablets 20 mg/die six weeks
Drug: simvastatin tablets
simvastatin tablets 20 mg/die
Drug: placebo
placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699023


Locations
Italy
Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Study Chair: Gabriele Riccardi, Prof Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
  More Information

Publications:
Responsible Party: Angela A. Rivellese, MD, Department of Clinical and Experimental Medicine Federico II University Naples
ClinicalTrials.gov Identifier: NCT00699023     History of Changes
Other Study ID Numbers: 239/07
First Submitted: June 13, 2008
First Posted: June 17, 2008
Last Update Posted: November 4, 2009
Last Verified: November 2009

Keywords provided by Federico II University:
postprandial lipemia
type 2 diabetes
ezetimibe
hypercholesterolemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hyperlipidemias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors