Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT04088370

Conditions

Alcoholic Hepatitis

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Blood Draw

Study Details

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

Conditions

Alcoholic Hepatitis

Study ID

NCT04088370

Start date

Oct 8, 2019

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Alcoholic Hepatitis

No intervention-blood draw only

Healthy Controls

No intervention- blood draw only

Healthy Heavy Drinkers

No intervention- blood draw only

Interventions

Blood Draw

Blood Draw Only

Primary outcome measure

  • Quantify mitochondrial respiration [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Annette Bellar

2164456268bellara@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Annette Bellar, BS

216-445-6268bellara@ccf.org

Revathi Penumatsa

penumar@ccf.org

Principal Investigator:

Srinivasan Dasarathy, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.