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

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04088370
Collaborator
(none)
30
1
49.8
0.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Draw

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
Actual Study Start Date :
Oct 8, 2019
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Alcoholic Hepatitis

No intervention-blood draw only

Other: Blood Draw
Blood Draw Only

Healthy Controls

No intervention- blood draw only

Other: Blood Draw
Blood Draw Only

Healthy Heavy Drinkers

No intervention- blood draw only

Other: Blood Draw
Blood Draw Only

Outcome Measures

Primary Outcome Measures

  1. Quantify mitochondrial respiration [1 day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Foundation Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Srinivasan Dasarathy, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT04088370
Other Study ID Numbers:
  • 19-1041
First Posted:
Sep 12, 2019
Last Update Posted:
Dec 9, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2021