Postprandial Lipemia, Type 2 Diabetes
Conditions
Keywords
postprandial lipemia, type 2 diabetes, ezetimibe, hypercholesterolemia
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.
Interventions
ezetimibe tablets 10 mg/die
simvastatin tablets 20 mg/die
DRUGplacebo
placebo
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions | 6 weeks |
Secondary
| Measure | 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 |
Countries
Italy
Outcome results
None listed