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

NCT04088370 | Recruiting

• 1 other identifier: 19-1041
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Quantify mitochondrial respiration

  Mitochondrial Respiration will be quantified by using a standard substrate, uncoupler, inhibitor titration protocol using high resolution respirometry

  1 day

Study Arms (3)

Alcoholic Hepatitis

No intervention-blood draw only

Other: Blood Draw

Healthy Controls

No intervention- blood draw only

Other: Blood Draw

Healthy Heavy Drinkers

No intervention- blood draw only

Other: Blood Draw

Interventions

Blood Draw OTHER

Blood Draw Only

Alcoholic Hepatitis; Healthy Controls; Healthy Heavy Drinkers

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with alcoholic hepatitis as diagnosed by liver biopsy, imaging, or biochemical values with noted encounter in Cleveland Clinic Electronic Medical Record, Heavy Drinking Controls - patients who lack any evidence (biochemical, imaging, and/or biopsy) of alcoholic liver disease who consume \>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 Healthy Controls - patients without any form of liver disease nd do not meet the criteria for "Heavy Drinking Controls"

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral Blood Mononuclear Cells, ethylenediaminetetraacetic acid (EDTA) plasma and serum will be collected

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Annette Bellar

CONTACT

2164456268; bellara@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: October 8, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)