Hepatic Lipid Metabolism in Alcohol Use Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will perform liver biopsies at the start of inpatient detoxification and again four weeks later when steatosis has resolved. Researchers will analyze hepatic transcriptomes to understand changes in lipid metabolism related to alcohol use and cessation. The aim is to map how gene expression in the liver shifts during detoxification and how these changes relate to lipid pathways and metabolomics. Stool microbiome data are also collected to explore connections with host metabolism. The study is centered at the NIH Clinical Center and involves adults with alcohol use disorder and hepatic steatosis.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Theo Heller, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Sawsan Fathma, M.D.
• Email: sawsan.fathma@nih.gov
• Phone: (301) 451-1273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.