Hepatic Lipid Metabolism-Alcohol Use Disorder
Recruiting now
Conditions studied: Alcohol Use Disorder
In brief
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 fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,
Key facts
- Study ID
- NCT07191561
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 25
- Starts
- 2026-08-13
- Expected to finish
- 2029-11-30
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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