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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 : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Srinivasan Dasarathy, The Cleveland Clinic

Tracking Information
First Submitted Date September 11, 2019
First Posted Date September 12, 2019
Last Update Posted Date November 18, 2019
Actual Study Start Date October 8, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04088370 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
Official Title Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With 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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Peripheral Blood Mononuclear Cells, ethylenediaminetetraacetic acid (EDTA) plasma and serum will be collected
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"

Condition Alcoholic Hepatitis
Intervention Other: Blood Draw
Blood Draw Only
Study Groups/Cohorts
  • Alcoholic Hepatitis
    No intervention-blood draw only
    Intervention: Other: Blood Draw
  • Healthy Controls
    No intervention- blood draw only
    Intervention: Other: Blood Draw
  • Healthy Heavy Drinkers
    No intervention- blood draw only
    Intervention: Other: Blood Draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 11, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Annette Bellar 2164456268 ext 2164456268 bellara@ccf.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04088370
Other Study ID Numbers 19-1041
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Srinivasan Dasarathy, The Cleveland Clinic
Study Sponsor The Cleveland Clinic
Collaborators Not Provided
Investigators Not Provided
PRS Account The Cleveland Clinic
Verification Date September 2019