NCT05365425招募中4 期
Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 56
- 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 choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
详细描述
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate 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 —（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: triglyceride 200~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL
- •Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- •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
- •Severe renal dysfunction
- •GOT/GPT >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
- •Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)
研究组 & 干预措施
Policosanol 10
Active Comparator
Policosanol 10mg 1 tablet once daily oral administration
干预措施: Policosanol (Drug)
Tgfenon
Experimental
Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet
干预措施: Choline fenofibrate (Drug)
结局指标
主要结局
Carotid intima media thickness
时间窗: 24 week
Maximum carotid IMT (mm)
次要结局
- Plaque characteristics(24 week)
- Proteinuria(24 week)
- Bioelectrical Impedance Analysis(24 week)
- Glucose homeostasis(24 week)
- Area of carotid artery plaque(24 week)
- Lipid metabolism(24 week)
- changes of gut microbiota(24 week)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital
研究点 (2)
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