Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.
研究概览
简要总结
Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,
详细描述
Study Description:
The liver is central to lipid metabolism, intimately involved with lipid uptake, lipoprotein synthesis and lipid synthesis. Alcohol has known effects on changing lipid composition including increases in HDL and decreases in LDL; nevertheless, the underlying mechanisms of this altered lipoprotein metabolism is not understood. Current spectroscopy data characterize the changes in lipoprotein profiles with alcohol cessation. We aim to study liver lipid metabolism by performing liver biopsies and transcriptome analysis in participants with alcohol use disorder.
Objectives:
Primary Objective:
To understand the transcriptomics of hepatic lipid metabolism in alcohol use disorder
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Any individual >=18 years of age who is enrolled in 14-AA-0181 and is seeking inpatient treatment.
- •Vibration Controlled Elastography parameters with initial CAP of >295dB/m.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Pregnancy
- •Existing diagnosis of hyperlipidemia or essential hypertension
- •Hemoglobin A1c >= 6.5%
- •Waist to hip ratio: >=0.90 in males, >=0.85 in females
- •Existing use of cholesterol lowering medications including statins, fibrates, or other similar medications used for the purposes of treating hyperlipidemia.
- •Those with evidence of severe alcoholic hepatitis with a Maddrey s Discriminant Function > 32
- •Those with other chronic liver diseases including chronic hepatitis B (positive hepatitis B surface Ag on admission), hepatitis C (positive hepatitis C RNA), or autoimmune hepatitis (clinical diagnosis based on high titer of positive ANA and or anti smooth muscle Ab and a history of autoimmune disease)
- •HIV infection
- •Contraindication or inability to perform a liver biopsy.
- •Participants with coagulopathy (PT/PTT values that are prolonged (Bullet) 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (< 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude participants, unless they cannot be stopped safely for the performance of a liver biopsy.
- •Hemoglobin level < 11 g/dL
- •Inability to provide informed consent.
研究组 & 干预措施
Liver biopsy
All participants in the study will undergo liver biopsies
干预措施: Liver biopsy (Diagnostic Test)
结局指标
主要结局
Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.
时间窗: November 2029
Analysis of liver biopsies
次要结局
- Other transcriptome changes between week 1 and week 4 of alcohol cessation(November 2029)