Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- HDL subpopulation analysis
研究概览
简要总结
Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%.
This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.
详细描述
Tibolone decreases plasma concentrations of HDL cholesterol and HDL-apoA1 and pre-beta HDL, consistent with a pro-atherogenic effect. The mechanism of tibolone on HDL cholesterol has been suggested to result from an acceleration of the catabolism of HDL by stimulation of hepatic lipase with no effect on cellular cholesterol efflux.
PPAR-a agonists, in particular fenofibrate, improve HDL metabolism by increasing the expression and hepatic secretion of HDL apoAI and apoAII.
We hypothesise that fenofibrate will rectify the perturbations on HDL metabolism wrought by tibolone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal women
- •More than 6 months of amenorrhoea
- •Raised FSH and low oestradiol level
- •If hysterectomised, raised FSH and low oestradiol level
排除标准
- •Renal failure
- •Proteinuria
- •High alcohol intake
- •Regular endurance exercise
- •Active weight loss of dieting
- •Agents known to influence lipid metabolism
- •Major systemic illness
- •Intolerance to tibolone and fenofibrate
- •Cholelithiasis
- •CK and ALT > 2ULN
- •Bleeding disorders
- •Peptic ulcer disease.
研究组 & 干预措施
1
fenofibrate and tibolone
干预措施: fenofibrate and tibolone (Drug)
2
tibolone
干预措施: tibolone (Drug)
结局指标
主要结局
HDL subpopulation analysis
时间窗: August 2009
次要结局
- Increase in HDL subpopulations(December 2009)