Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Carotid intima media thickness
Study Overview
Brief Summary
This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.
Detailed Description
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
- •Male or female of 20 years or over
- •Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL
- •moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg
- •Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- •Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
- •Creatinine ≤1.8 mg/dL
Exclusion Criteria
- •Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
- •Uncontrolled hypertension: SBP >180 mmHg or DBP >110 mmHg
- •Severe renal dysfunction: eGFR <30 mL/min/1.73m2
- •AST/ALT >120/120 or chronic liver disease
- •Pregnant or childbearing woman who does not have enough contraception
- •Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
- •Usage of dyslipidemia therapy other than statin
Arms & Interventions
Atmeg with Omethyl Cutielet
Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Omethyl Cutielet: Omega-3 2000mg (920mg as EPA ethyl ester, 760mg as DHA ethyl ester) once daily
Intervention: Omega 3-Atorvastatin (Drug)
Atmeg
Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)
Intervention: Omega 3-Atorvastatin (Drug)
ezetimibe/atorvastatin 10/20
1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)
Intervention: Atorvastatin-Ezetimibe (Drug)
Outcomes
Primary Outcomes
Carotid intima media thickness
Time Frame: 24 weeks
maximum carotid IMT (mm)
Secondary Outcomes
- Area of carotid artery plaque(24 weeks)
- Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics(24 weeks)
- Glucose homeostasis(24 weeks)
- Lipid metabolism(24 weeks)
- Bioelectrical Impedance Analysis(24 weeks)
- Proteinuria(24 weeks)
- Changes of gut microbiota(24 weeks)
Investigators
Soo Lim
Professor
Seoul National University Bundang Hospital