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

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ClinicalTrials.gov Identifier: NCT04088370
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Srinivasan Dasarathy, The Cleveland Clinic

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
Alcoholic Hepatitis Other: Blood Draw

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Study Type : Observational
Estimated 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
Estimated Study Start Date : September 14, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Quantify mitochondrial respiration [ Time Frame: 1 day ]
    Mitochondrial Respiration will be quantified by using a standard substrate, uncoupler, inhibitor titration protocol using high resolution respirometry


Biospecimen Retention:   Samples Without DNA
Peripheral Blood Mononuclear Cells, ethylenediaminetetraacetic acid (EDTA) plasma and serum will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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"

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088370


Contacts
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Contact: Annette Bellar 2164456268 ext 2164456268 bellara@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Annette Bellar, BS    216-445-6268    bellara@ccf.org   
Contact: Revathi Penumatsa       penumar@ccf.org   
Principal Investigator: Srinivasan Dasarathy, MD         
Sponsors and Collaborators
The Cleveland Clinic

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Responsible Party: Srinivasan Dasarathy, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04088370     History of Changes
Other Study ID Numbers: 19-1041
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Alcoholic Intoxication
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders