NCT00659321已完成3 期
Placebokontrollierte Untersuchung Zur Wirkung Von Nikotinsäure Auf Die Dyslipidämie Bei Metabolischem Syndrom Und Das Arterioskleroserisiko (Placebo Controlled Investigation of Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome and the Risk of Atherosclerosis)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome
研究概览
简要总结
Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation and the risk of atherosclerosis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol <40 mg/dl in men or < 50 mg/dl in women)
- •further components of the metabolic syndrome: Hypertension: blood pressure >= 130/85 mmHg or/and Hyperglycemia: fasting plasma glucose >= 100 mg/dl or/and 2 hour plasma glucose after 75g glucose load (OGTT) >= 140 mg/dl or/and Obesity: waist circumferences > 102 cm in men or >88 cm in women
排除标准
- •Contraindication and incompatibility of nicotine acid
- •Patients with ulcus ventriculi or ulcus duodeni
- •Intake of lipid lowering drugs < 6 weeks before randomization
- •therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit) - no acceptable therapy of diabetes with levels of HbA1C>=8.0%
- •cardiovascular events in the last 6 months
- •chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
- •ALAT elevation 2.5 times more than the normal limit
- •pregnancy
研究组 & 干预措施
1
Active Comparator
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
干预措施: nicotine acid (Drug)
2
Placebo Comparator
16 weeks treatment with placebo
干预措施: placebo (Drug)
结局指标
主要结局
Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome
时间窗: after 16 weeks treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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