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

NCT ID: NCT04088370

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-08

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Alcoholic Hepatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alcoholic Hepatitis

No intervention-blood draw only

Blood Draw

Intervention Type OTHER

Blood Draw Only

Healthy Controls

No intervention- blood draw only

Blood Draw

Intervention Type OTHER

Blood Draw Only

Healthy Heavy Drinkers

No intervention- blood draw only

Blood Draw

Intervention Type OTHER

Blood Draw Only

Interventions

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Blood Draw

Blood Draw Only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\*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

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Srinivasan Dasarathy

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Annette Bellar

Role: CONTACT

2164456268 ext. 2164456268

Facility Contacts

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Annette Bellar, BS

Role: primary

216-445-6268

Revathi Penumatsa

Role: backup

Other Identifiers

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19-1041

Identifier Type: -

Identifier Source: org_study_id

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