Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

Study Overview
=================
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.

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

Conditions
-----------------
Postprandial Lipemia, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ezetimibe tablets
* Drug: simvastatin tablets
* Drug: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks | Drug: ezetimibe tablets<br>* ezetimibe tablets 10 mg/die<br>Drug: simvastatin tablets<br>* simvastatin tablets 20 mg/die<br>|
| Placebo Comparator: 2<br>placebo + simvastatin tablets 20 mg/die six weeks | Drug: simvastatin tablets<br>* simvastatin tablets 20 mg/die<br>Drug: placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fasting LDL concentration |  | 6 weeks | 
| Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. |  | 6 weeks | 
| Postprandial LDL size |  | 6 weeks | 
| Concentration and Composition of different lipoprotein subclasses in the fasting condition. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postprandial lipemia, type 2 diabetes, ezetimibe, hypercholesterolemia