Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
25 participants
OBSERVATIONAL
2025-12-30
2029-11-30
Brief Summary
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Detailed Description
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The liver is central to lipid metabolism, intimately involved with lipid uptake, lipoprotein synthesis and lipid synthesis. Alcohol has known effects on changing lipid composition including increases in HDL and decreases in LDL; nevertheless, the underlying mechanisms of this altered lipoprotein metabolism is not understood. Current spectroscopy data characterize the changes in lipoprotein profiles with alcohol cessation. We aim to study liver lipid metabolism by performing liver biopsies and transcriptome analysis in participants with alcohol use disorder.
Objectives:
Primary Objective:
To understand the transcriptomics of hepatic lipid metabolism in alcohol use disorder
Secondary Objective:
To understand other transcriptome changes in alcohol use cessation.
Tertiary Objective:
To elucidate the genomics-transcriptomics-metabolomics pathway of hepatic lipid metabolism in alcohol use disorder.
Endpoints:
Primary Endpoints:
-Transcriptome changes in lipid metabolism between week 1 and week 4.
Secondary Endpoints:
-Other transcriptome changes between week 1 and week 4.
Tertiary Endpoints:
* To make connections with existing genetics and metabolomics data with transcriptomics.
* Stool microbiome studies
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Liver biopsy
All participants in the study will undergo liver biopsies
Liver biopsy
Biopsy of the liver
Interventions
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Liver biopsy
Biopsy of the liver
Eligibility Criteria
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Inclusion Criteria
* Any individual \>=18 years of age who is enrolled in 14-AA-0181 and is seeking inpatient treatment.
* Vibration Controlled Elastography parameters with initial CAP of \>295dB/m.
Exclusion Criteria
* Pregnancy
* Existing diagnosis of hyperlipidemia or essential hypertension
* Hemoglobin A1c \>= 6.5%
* Waist to hip ratio: \>=0.90 in males, \>=0.85 in females
* Existing use of cholesterol lowering medications including statins, fibrates, or other similar medications used for the purposes of treating hyperlipidemia.
* Those with evidence of severe alcoholic hepatitis with a Maddrey s Discriminant Function \> 32
* Those with other chronic liver diseases including chronic hepatitis B (positive hepatitis B surface Ag on admission), hepatitis C (positive hepatitis C RNA), or autoimmune hepatitis (clinical diagnosis based on high titer of positive ANA and or anti smooth muscle Ab and a history of autoimmune disease)
* HIV infection
* Contraindication or inability to perform a liver biopsy.
* Participants with coagulopathy (PT/PTT values that are prolonged (Bullet) 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\< 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude participants, unless they cannot be stopped safely for the performance of a liver biopsy.
* Hemoglobin level \< 11 g/dL
* Inability to provide informed consent.
18 Years
100 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Theo Heller, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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001764-DK
Identifier Type: -
Identifier Source: secondary_id
10001764
Identifier Type: -
Identifier Source: org_study_id