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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 2026 → Dec 31, 2028
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Record History

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  1. Primary and study completion pushed from Dec 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 7 words
  2. Primary and study completion dates: Dec 2025 to Dec 2026v10
  3. Primary and study completion dates: Dec 2024 to Dec 2025v9
  4. Primary and study completion dates: Dec 2023 to Dec 2024v8
  5. 2 versions Re-verified since Oct 19, 2022, no change to tracked fieldsv6-v7
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  1. Primary and study completion dates: Sep 2021 to Dec 2023v5
  2. Re-verified, no change to tracked fieldsv4
  3. Start date changed from estimate of Sep 14, 2019 to Oct 8, 2019v3
  4. Eligibility criteria shortened, about 33 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04088370
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Alcoholic Hepatitis
Related terms Hepatitis, Alcoholic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov