Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evolution of non-esterified fatty acid and triglycerides concentrations over time
研究概览
简要总结
Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the drug has been used for so long, its precise mechanism of action remains elusive. The aim of this study was to characterise the metabolic changes induced by 8 week treatment with Niacin in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. In order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.
详细描述
24 patients will be included in a double blind placebo controlled cross-over 8 week study comparing placebo to Niaspan (a long release formulation of niacin). In order to prevent any drop out linked to the flushing side effect of niacin, patient will take aspirin (300mg) prior to treatment throughout the study duration. The study will include at start and end of each arm, a full lipoproteins quantification as well as a measure of enzymes involved in lipid metabolism. On day 42 and 56 of each period, after an administration of either placebo or 500mg of immediate release niacin respectively, changes in plasma free fatty acid levels will be measured for 8hours in order to assess potential loss of activity of niacin over time upon chronic treatment with niaspan. Half of the patient will have an exploration of their glucose metabolism using hyperinsulinic clamp technique, whereas in the other half a metabolic turnover study using stable isotopes will focus on their lipoproteins, triglycerides and cholesterol handling. These explorations will be done at the end of each treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Waist circumference > 94cm
- •Triglyceride concentration between 150mg/dL and 400mg/dL
- •HDL-c < 60mg/dL
- •Body mass index: 27 to 35 kg/m²
排除标准
- •diabetes mellitus
- •hepatic, renal or digestive disorder
- •hypertension
- •chronic medical treatment interfering on lipids parameters
研究组 & 干预措施
Extended release nicotinic acid
干预措施: Extended-release nicotinic acid versus placebo (Drug)
Placebo
干预措施: Extended-release nicotinic acid versus placebo (Drug)
结局指标
主要结局
Evolution of non-esterified fatty acid and triglycerides concentrations over time
时间窗: After 42 and 56 days of placebo or nicotinic acid treatment
Twelve hours after ingestion of chronic treatment, measures of non esterified fatty acid and triglycerides concentrations were carried out during 480 minutes to assess acute and chronic treatment effect on lipolysis and on triglyceride concentration. To appreciate both acute and chronic effects, subjects received medicinal supplements in addition to their chronic treatment: * On day 42, 500 mg of placebo to assess chronic nicotinic acid effect versus placebo effect * On day 56, 500 mg of immediate-release nicotinic acid (INA) to assess acute versus chronic nicotinic acid effect.
次要结局
- Insulin sensitivity after treatment(After 53 days of placebo or nicotinic acid treatment)
- Lipoproteins metabolism(After 53 days of placebo or nicotinic acid treatment)
- Lipid profile(Before and after placebo or nicotinic acid treatment)