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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04088370
Status
Recruiting

Conditions

  • Alcoholic Hepatitis

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Blood Draw — OTHER
    Blood Draw Only

Study Details

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

Key Dates

Start date
Oct 8, 2019
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Alcoholic Hepatitis
    No intervention-blood draw only
  • Arm: Healthy Controls
    No intervention- blood draw only
  • Arm: Healthy Heavy Drinkers
    No intervention- blood draw only

Primary Outcome Measure

Quantify mitochondrial respiration [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Annette Bellar, BS
216-445-6268
Revathi Penumatsa
Srinivasan Dasarathy, MD (PRINCIPAL_INVESTIGATOR)

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