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

Primary Purpose

Postprandial Lipemia, Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ezetimibe tablets
simvastatin tablets
placebo
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postprandial Lipemia focused on measuring postprandial lipemia, type 2 diabetes, ezetimibe, hypercholesterolemia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks

placebo + simvastatin tablets 20 mg/die six weeks

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 13, 2008
Last Updated
November 3, 2009
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT00699023
Brief Title
Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes
Acronym
EZE
Official Title
Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Lipemia, Type 2 Diabetes
Keywords
postprandial lipemia, type 2 diabetes, ezetimibe, hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo + simvastatin tablets 20 mg/die six weeks
Intervention Type
Drug
Intervention Name(s)
ezetimibe tablets
Intervention Description
ezetimibe tablets 10 mg/die
Intervention Type
Drug
Intervention Name(s)
simvastatin tablets
Intervention Description
simvastatin tablets 20 mg/die
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
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
Title
Fasting LDL concentration
Time Frame
6 weeks
Title
Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.
Time Frame
6 weeks
Title
Postprandial LDL size
Time Frame
6 weeks
Title
Concentration and Composition of different lipoprotein subclasses in the fasting condition.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Riccardi, Prof
Organizational Affiliation
Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Clinical and Experimental Medicine, Federico II University Hospital,
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15126535
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.
Results Reference
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PubMed Identifier
15458975
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.
Results Reference
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PubMed Identifier
15243215
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.
Results Reference
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Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

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