Actively Recruiting

Age: 21Years - 65Years
All Genders
Healthy Volunteers
NCT04088370

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

Led by The Cleveland Clinic · Updated on 2025-11-25

30

Participants Needed

1

Research Sites

373 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of alcoholic hepatitis confirmed by imaging, biochemical values, or liver biopsy along with drinking history
  • Heavy drinking defined as >40 g/day or >280 g/week for women and >60 g/day or >420 g/week for men for at least 6 months and within 4 weeks prior to enrollment
  • Age between 21 and 65 years
Not Eligible

You will not qualify if you...

  • Inability or unwillingness to sign informed consent
  • History of cancer
  • Autoimmune disease that may affect study data as judged by the principal investigator
  • For control subjects: INR must be less than 1.4
  • For control subjects: Total bilirubin levels less than 3
  • No prior known alcoholic liver disease
  • No hepatosplenomegaly or signs of liver disease based on physical exam or imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

A

Annette Bellar

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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