LXRA Gene Polymorphisms and Response to Fenofibrate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Log(ENA-Period 2 End/ENA Period 1 End)
研究概览
简要总结
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.
详细描述
This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)
- •Must be able to swallow tablets
排除标准
- •Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%
- •Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain
- •Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs
- •Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine
研究组 & 干预措施
1-Fenofibrate then Placebo
4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo
干预措施: Fenofibrate capsule daily for 4 weeks (Drug)
1-Fenofibrate then Placebo
4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo
干预措施: Fenofibrate (Drug)
2 Placebo then Fenofibrate
4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
干预措施: Fenofibrate capsule daily for 4 weeks (Drug)
2 Placebo then Fenofibrate
4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Log(ENA-Period 2 End/ENA Period 1 End)
时间窗: week 12 to week 4
Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects. Natural logs used
次要结局
未报告次要终点