Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis

Launched by THE CLEVELAND CLINIC · Sep 11, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how the body’s immune response and cell function are affected by alcohol, particularly in people with alcoholic hepatitis, heavy drinkers, and healthy individuals. Researchers want to understand how these responses differ among these groups by analyzing blood samples. They will look at factors like inflammation, cell function, and how the body processes fats and sugars. This research could help identify important changes that happen in the body due to heavy drinking and alcoholic liver disease.

To participate in this study, you need to be either diagnosed with alcoholic hepatitis, a heavy drinker, or a healthy control. Heavy drinking is defined as consuming a certain amount of alcohol daily or weekly for a minimum of six months. Participants should not have a history of liver disease, cancer, or certain autoimmune diseases. If eligible, you can expect to give a blood sample, and the study will monitor various health markers. This research is currently recruiting participants of all genders, aged between 18 and 70 years, and aims to contribute valuable insights into the effects of alcohol on health.

Gender

ALL

Eligibility criteria

• 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.
• • Exclusion Criteria for all groups
• • inability or unwillingness to sign informed consent
• • cancer
• • 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.