Investigating blood responses in healthy individuals, heavy drinkers, and patients with alcoholic hepatitis
Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
This study looks at how blood responses differ between healthy people, heavy drinkers, and those with alcoholic hepatitis to better understand inflammation and liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04088370 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the inflammatory responses and mitochondrial function in Peripheral Blood Mononuclear Cells (PBMCs) from three groups: healthy controls, heavy drinkers, and patients diagnosed with alcoholic hepatitis. By collecting blood samples, the study will compare cytokine responses, fatty acid metabolism, and glucose and insulin levels among these groups. The goal is to better understand the role of inflammation and mitochondrial perturbations in the progression of alcoholic liver disease.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with alcoholic hepatitis, heavy drinkers, and healthy controls without liver disease.
Not a fit: Patients with cancer or autoimmune diseases that may confound the study data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and potential new therapeutic targets for alcoholic hepatitis.
How similar studies have performed: While there have been few studies targeting mitochondrial function in PBMCs, this approach is relatively novel and untested in the context of alcoholic hepatitis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Annette Bellar
- Email: bellara@ccf.org
- Phone: 2164456268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.