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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04088370
Enrollment
30
Registered
2019-09-12
Start date
2019-10-08
Completion date
2026-12-31
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

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

Interventions

OTHERBlood Draw

Blood Draw Only

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Quantify mitochondrial respiration1 dayMitochondrial Respiration will be quantified by using a standard substrate, uncoupler, inhibitor titration protocol using high resolution respirometry

Countries

United States

Contacts

Primary ContactAnnette Bellar
bellara@ccf.org2164456268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026