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Hepatic Lipid Metabolism-Alcohol Use Disorder

NCT07191561

RecruitingN/A

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions: Alcohol Use Disorder

Interventions: Liver biopsy

Countries: United States

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,

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

* 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.

Locations (1)

Bethesda, Maryland, United States