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NCT04088370 · ClinicalTrials.gov registry record

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

A clinical trial of Alcoholic Hepatitis, sponsored by The Cleveland Clinic.

Recruiting
Registry status
30
Enrollment target
1
Study location

NCT04088370: Recruiting study of Alcoholic Hepatitis, sponsored by The Cleveland Clinic.

NCT04088370 is a study of Alcoholic Hepatitis that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 30 participants, below the 295-participant average among 5 other Alcoholic Hepatitis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04088370, a study of Alcoholic Hepatitis, is actively recruiting participants, sponsored by The Cleveland Clinic.

RECRUITING
Registry status
30 participants
Enrollment target
1
Study location

Study 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

Primary Outcome

Mitochondrial Respiration will be quantified by using a standard substrate, uncoupler, inhibitor titration protocol using high resolution respirometry

Conditions Studied

Interventions

  • OTHER Blood Draw

Study Locations (1)

Ohio

  • Cleveland Clinic Foundation - Cleveland

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2019-10-08
Est. Completion 2026-12
The Cleveland Clinic

688 total trials

What NCT04088370 shows while recruiting

NCT04088370 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 295-participant average among 5 other Alcoholic Hepatitis trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Alcoholic Hepatitis appearing as the primary indexed condition, and to 1 intervention - of which Blood Draw is the first listed.

NCT04088370 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT04088370 about?

NCT04088370 is a clinical study titled "Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis". 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 mitochond...

What is the current status of trial NCT04088370?

This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2019-10-08. Estimated completion is 2026-12.

What conditions does trial NCT04088370 study?

This clinical trial studies the following conditions: Alcoholic Hepatitis.

What interventions are being tested in trial NCT04088370?

The interventions under investigation include: Blood Draw (OTHER).

Who is sponsoring clinical trial NCT04088370?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04088370 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04088370, the US trial registry maintained by the National Library of Medicine. NCT04088370 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.