Status:
NOT_YET_RECRUITING
Hepatic Lipid Metabolism-Alcohol Use Disorder
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-100 years
Brief Summary
Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the...
Detailed Description
Study Description: 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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following 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:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
Exclusion
Key Trial Info
Start Date :
January 14 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07191561
Start Date
January 14 2026
End Date
November 30 2029
Last Update
January 9 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892