NCT01239992终止4 期
Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test
研究概览
简要总结
The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects or postmenopausal female subjects aged between 19-70 years
- •High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d
- •HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl
- •Lipoprotein (a) < 30 mg/dl
- •Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus.
- •Without niacin therapy for at least 6 months
- •Dosage of any concomitant medication has been stable for at least 3 weeks
- •If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml)
排除标准
- •Subjects with additional causes for hyperlipoproteinemia
- •Diabetes mellitus or antidiabetic medication
- •Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
- •History of psychiatric disorder or cognitive impairment that would interfere with participation in the study
- •History of alcoholism
- •Contraindication against niacin and/or laropiprant
- •Subject has participated in an investigational study within 30 days prior to study initiation
- •Fasting triglycerides >400 mg/dl
- •Life-threatening disease (e.g. cancer)
- •Renal insufficiency (GFR ≤ 30 ml/min )
- •Major hepatic impairment
- •Known allergic reaction/intolerance against niacin and/or laropiprant
- •Active peptic ulcer disease
研究组 & 干预措施
Niacin/ Laropiprant
Experimental
干预措施: Niacin/ Laropiprant (Drug)
结局指标
主要结局
Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test
时间窗: baseline and 12 weeks after treatment
Percent change of incremental AUC at 12 weeks compared to baseline.
次要结局
- HDL Cholesterol(baseline and 12 weeks after treatment)
- Fasting Triglycerides(baseline and 12 weeks after treatment)
研究者
Klaus Parhofer
Professor of Medicine
Ludwig-Maximilians - University of Munich
研究点 (1)
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