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NCT07191561From ClinicalTrials.govRecruiting

Hepatic Lipid Metabolism-Alcohol Use Disorder

Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics

  • Alcohol Use Disorder

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrolment target
25
Started
4 October 2026
Main results due
30 November 2027
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 100 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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,

Study sites(1)

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07191561. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Hepatic Lipid Metabolism-Alcohol Use Disorder | Trialion