Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quantify mitochondrial respiration
研究概览
简要总结
Inflammatory responses in response to alcohol have been identified as contributing to the development of alcoholic hepatitis. The inflammatory response including that to LippoPolySaccharide is known to lead to progression of alcoholic liver disease. In addition to the inflammatory response mitochondrial perturbations exist and redox homeostasis is altered in patients with alcoholic hepatitis. Though this is known there have been very few studies targeting mitochondrial function in Peripheral Blood Mononuclear Cells (PBMCs). We plan to collect 50 milliliters of blood from healthy control patients so that we can compare the data to that of patients with alcoholic hepatitis and those who are heavy drinkers without liver disease. In addition to studying mitochondrial function we will investigate cytokine response, as well as fatty acid metabolism, glucose, and insulin measurements
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Inclusion of Subjects with Alcoholic Hepatitis (AH):
- •*diagnosis of AH either by imaging, biochemical values or liver biopsy as well as drinking history
- •Inclusion Heavy Drinking Controls:
- •*heavy alcohol drinking will be defined as >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men for a minimum of 6 months [6] and within the 4 weeks prior to study enrollment.
排除标准
- •for all groups
- •inability or unwillingness to sign informed consent
- •autoimmune disease that in the opinion of the PI will confound study data
- •Control subjects (drinking and non drinking) must meet the following criteria:
- •INR < 1.4
- •total bilirubin levels must <3
- •no prior history of known alcoholic liver disease
- •absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.
研究组 & 干预措施
Alcoholic Hepatitis
No intervention-blood draw only
干预措施: Blood Draw (Other)
Healthy Controls
No intervention- blood draw only
干预措施: Blood Draw (Other)
Healthy Heavy Drinkers
No intervention- blood draw only
干预措施: Blood Draw (Other)
结局指标
主要结局
Quantify mitochondrial respiration
时间窗: 1 day
Mitochondrial Respiration will be quantified by using a standard substrate, uncoupler, inhibitor titration protocol using high resolution respirometry
次要结局
未报告次要终点
研究者
Srinivasan Dasarathy
Staff Physician
The Cleveland Clinic