Health TrialsbyHealthPanel

Hepatic Lipid Metabolism-Alcohol Use Disorder

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy

Existing diagnosis of hyperlipidemia or essential hypertension

Hemoglobin A1c >= 6.5%

Waist to hip ratio: >=0.90 in males, >=0.85 in females

Trial population

Participants diagnosed with alcohol use disorder, currently under inpatient treatment at the NIH.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Liver biopsy

    Diagnostic test

    Biopsy of the liver

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Liver biopsy1 intervention

Trial outcomes

Primary outcomes

1

Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.

Analysis of liver biopsies

Time frame
November 2029

Secondary outcomes

1

Other transcriptome changes between week 1 and week 4 of alcohol cessation

Time frame
November 2029

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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