The study for beneficial efficacy and safety of ezetimibe in patients with hyper LDL-cholesterolemia associated with diabetes mellitus (DM) including glucose intolerance and non-alcoholic fatty liver disease (NAFLD)
- Conditions
- non-alcoholic fatty liver disease, diabetes mellitus, hyper LDL-cholesterolemia
- Registration Number
- JPRN-UMIN000004462
- Lead Sponsor
- Geriatric Medicine, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1) the subjects currently receiving ezetimibe 2) the subjects infected with hepatitis B or C virus 3) the subjects with more than 500mg/dl of triglyceride 4) the subjects with familial hyperlipidemia, secondary hyperlipidemia and drug induced-hyperlipidemia 5) the subjects drinking alcohol more than 21g per day frequently 6) the subjects receiving pioglitazone 7) the subjects recommended the other medication 8) the subjects with hyperlipidemia induced by: hypothyroidism, obstructive biliary tract disease, pancreatitis, cushing syndrome, lupus erythematosus, malignant lymphoma, myeloma. 9) the subjects with poor controlled diabetes (HbA1c > 9.0%) 10) the subjects having a history of a previous drug allergy 11) the subjects during pregnancy or lactation 12) the subjects found offensive by attending physicians for this research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of change in LDL-cholesterol level after 24 weeks from entry
- Secondary Outcome Measures
Name Time Method 1) the rate of change of fat accumulation in liver by abdominal ultrasound 2) the rate of change of hepatic function test 3) the rate of change of glucose tolerance 4) the rate of change of serum lipid level other than LDL-cholesterol 5) the rate of change of inflammatory markers 6) the rate of change of oxidative stress markers 7) safety