Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Carotid intima media thickness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Atmeg
Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)
干预措施: Omega 3-Atorvastatin (Drug)
ezetimibe/atorvastatin 10/20
1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)
干预措施: Atorvastatin-Ezetimibe (Drug)
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
干预措施: Omega 3-Atorvastatin (Drug)
结局指标
主要结局
Carotid intima media thickness
时间窗: 24 weeks
maximum carotid IMT (mm)
次要结局
- 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)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital