Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
- Alcoholic Hepatitis
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- The Cleveland Clinic
- Enrolment target
- 30
- Started
- 8 October 2019
- Main results due
- 31 December 2028
- Study sites
- 1
- Registry updated
- 24 September 2026
Can you take part?
- Ages 21 years to 65 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(1)
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04088370. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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