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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04088370
Other study ID # 19-1041
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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