Investigating blood responses in healthy individuals, heavy drinkers, and patients with alcoholic hepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to analyze the inflammatory responses and mitochondrial function in Peripheral Blood Mononuclear Cells (PBMCs) from three groups: healthy controls, heavy drinkers, and patients diagnosed with alcoholic hepatitis. By collecting blood samples, the study will compare cytokine responses, fatty acid metabolism, and glucose and insulin levels among these groups. The goal is to better understand the role of inflammation and mitochondrial perturbations in the progression of alcoholic liver disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Annette Bellar
• Email: bellara@ccf.org
• Phone: 2164456268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.