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

Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088370
• Other study ID #: 19-1041
• Status: Recruiting
• Start date: October 8, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: Annette Bellar
• Phone: 2164456268
• Email: bellara[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Alcoholic Intoxication
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Other:
• Blood Draw
Blood Draw Only

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify mitochondrial respiration	Mitochondrial Respiration will be quantified by using a standard substrate, uncoupler, inhibitor titration protocol using high resolution respirometry	1 day