None listed
Conditions
Interventions
Drug : Patients with dyslipidemia and type 2 DM or metabolic syndrome will go through a 4 week screening perid and be assigned to a treatment group by 1:1 randomization. Patients will either be given
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over age of 20 and with a LDL-cholesterol = 100mg/dL, who are not taking medication for dyslipidmeia in the 4 weeks prior to randomization. 2) Patient with either type 2 diabetes mellitus or metabolic syndrome (1) Type 2 diabetes mellitus - on oral hypoglycemic agents - newly diagnosed patients (HbA1c =6.5%, fasting bloos glucose =126mg/dL, PP2 =200mg/dL on post-prandial testing, or random glucose = 200mg/dL with specific symptoms of diabetes) (2) Metabolic syndrome - meeting 3 of the below criteria, accoring to NCEP ATP III guidelines modified to Korean standards ? Waist circumference >90 cm in men, >85 cm in women ? Triglycerides 150 mg/dL or greater ? HDL-cholesterol <40 mg/dL in men and <50 mg/dL in women ? BP 130/85 mmHg or greater, or on treatment for hypertension ? Fasting glucose 110 mg/dL or greater, or on treatment for diabetes
Exclusion criteria
Exclusion criteria: (1) Hypersensitivity to the study drug or its substance (2) Active liver disease, or AST/ALT levels over 5 times the upper limit of normal (3) Myopathy or serum CK levels over 5 times the upper limit of normal (4) Cyclosporine use (5) Moderate+ kidney dysfunction (creatinine clearance, CLcr <30mL/min) (6) Pregnancy or breasfeeeding (7) Alcoholic (8) Medications that may influence the lipid profile: - fibrate, bile acid sequestrants, niacin, drugs for management of obesity, systemic steroids, fish oil, fiber-based laxatives, phytosterol margarines, etc. - medications that influence thyroid function (medications for thyroid replacement therapies are allowed) (9) Other reasons that the investigator deems to be unfit for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change(%) in post-prandial TG | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in post-prandial TG;Absolute change and percentage change in post-prandial glucose;Absolute change and percentage change in TG/HDL ratio;Absolute change and percentage change in post-prandial Apo-B;Change in insulin sensitivity;Absolute change and percentage change in C-reactive protein;Percentage of patients reaching LDL-C target goal according to NCEP ATP III risk | — |
Countries
Korea, Republic of
Contacts
Public ContactGyu Chul Oh
Seoul National University Hospital
Outcome results
None listed