NCT02654236已完成不适用
Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling
Suthat Liangpunsakul1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
研究概览
简要总结
The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals ≥ 21 to 65 years old
- •Able to provide informed consent & negative urine pregnancy test where appropriate
- •Healthy controls must have not consumed any alcohol within 3 months prior to the screening visit
- •Heavy alcohol drinking is defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months
- •Women of child bearing potential should be willing to practice contraception throughout the treatment period
排除标准
- •Active infection as evidenced by positive urine culture, blood culture, or pneumonia
- •Serum creatinine > 1.5 mg/dL
- •Known co-existing infection with hepatitis C, hepatitis B, or HIV
- •Significant systemic or major illness including COPD, CHF and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study.
- •Participation in another investigational drug, biologic, or medical device trial within 30 days prior to Screening
- •Previous history of jaundice or signs of liver diseases such as spider angiomata, ascites, or history of esophageal varices or hepatic encephalopathy
- •Total bilirubin > 2 mg/dl and INR > 1.5 Page 20 of 37
- •Women who are pregnant or nursing
- •Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
- •Subjects who are taking warfarin
研究组 & 干预措施
Placebo
Placebo Comparator
Heavy Drinkers on placebo
干预措施: Placebo (Drug)
10 mg Obeticholic Acid (OCA)
Experimental
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks.
干预措施: 10 mg Obeticholic Acid (OCA) (Drug)
结局指标
主要结局
Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR
时间窗: Baseline to 28 days
Change in FGF19 Levels to Determine Effect of FXR
时间窗: Baseline to 28 days
次要结局
- Change in Fasting Serum Bile Salt Levels(Baseline to 28 days)
- Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance(Baseline to 28 days)
- Change in Activation of Innate Immunity Through Measures of IL-6(Baseline to 28 days)
- Change in Intestinal Inflammation by Measuring Stool Calprotectin(Baseline to 28 days)
- Change in Activation of Innate Immunity Through Measures of IL-8(Baseline to 28 days)
- Change in Activation of Innate Immunity Through Measures of IL-1(Baseline to 28 days)
- Change in Oxidative Stress Level by Measuring Malondialdehyde(Baseline to 28 days)
- Change in Gut Permeability Through Lactulose/Mannitol Test(Baseline to 28 days)
- Change in Bacterial Translocation Through Measures of Plasma LPS(Baseline to 28 days)
- Change in Bacterial Translocation Through Measures of Serum sCD14(Baseline to 28 days)
- Change in Activation of Innate Immunity Through Measures of TNF-alpha(Baseline to 28 days)
研究者
Suthat Liangpunsakul
Suthat Liangpunsakul, Associate Professor of Medicine, Biochemistry and Molecular Biology
Indiana University School of Medicine
研究点 (1)
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