Alcohol Use DisorderNCT07191561
Hepatic Lipid Metabolism-Alcohol Use Disorder
An observational study of Alcohol Use Disorder, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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, Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Liver biopsy
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 30 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with alcohol use disorder, currently under inpatient treatment at the NIH.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics
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,
Read the detailed description
Study Description:
The liver is central to lipid metabolism, intimately involved with lipid uptake, lipoprotein synthesis and lipid synthesis. Alcohol has known effects on changing lipid composition including increases in HDL and decreases in LDL; nevertheless, the underlying mechanisms of this altered lipoprotein metabolism is not understood. Current spectroscopy data characterize the changes in lipoprotein profiles with alcohol cessation. We aim to study liver lipid metabolism by performing liver biopsies and transcriptome analysis in participants with alcohol use disorder.
Objectives:
Primary Objective:
To understand the transcriptomics of hepatic lipid metabolism in alcohol use disorder
Secondary Objective:
To understand other transcriptome changes in alcohol use cessation.
Tertiary Objective:
To elucidate the genomics-transcriptomics-metabolomics pathway of hepatic lipid metabolism in alcohol use disorder.
Endpoints:
Primary Endpoints:
-Transcriptome changes in lipid metabolism between week 1 and week 4.
Secondary Endpoints:
-Other transcriptome changes between week 1 and week 4.
Tertiary Endpoints:
- To make connections with existing genetics and metabolomics data with transcriptomics.
- Stool microbiome studies
- Conditions
- Alcohol Use Disorder
- Being tested
- Liver biopsy
- Keywords
- Alcohol, Liver, Biopsy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsyDiagnostic test
Biopsy of the liver
| Study group | Role | What they receive |
|---|---|---|
| Liver biopsy | All participants in the study will undergo liver biopsies Receives: Diagnostic Test: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.
Analysis of liver biopsies
Measured: November 2029
Secondary outcomes (1)
Other transcriptome changes between week 1 and week 4 of alcohol cessation
Measured: November 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start5 Oct 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Theo Heller, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191561
- Sponsor's protocol ID
- 10001764
- Other IDs
- 001764-DK
- Status last verified
- 18 Aug 2026
- First submitted
- 24 Sep 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics
- ClinicalTrials.gov ID
- NCT07191561
- Acronym / sponsor ID
- 10001764
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, Liver, Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Detailed description
Study Description:
The liver is central to lipid metabolism, intimately involved with lipid uptake, lipoprotein synthesis and lipid synthesis. Alcohol has known effects on changing lipid composition including increases in HDL and decreases in LDL; nevertheless, the underlying mechanisms of this altered lipoprotein metabolism is not understood. Current spectroscopy data characterize the changes in lipoprotein profiles with alcohol cessation. We aim to study liver lipid metabolism by performing liver biopsies and transcriptome analysis in participants with alcohol use disorder.
Objectives:
Primary Objective:
To understand the transcriptomics of hepatic lipid metabolism in alcohol use disorder
Secondary Objective:
To understand other transcriptome changes in alcohol use cessation.
Tertiary Objective:
To elucidate the genomics-transcriptomics-metabolomics pathway of hepatic lipid metabolism in alcohol use disorder.
Endpoints:
Primary Endpoints:
-Transcriptome changes in lipid metabolism between week 1 and week 4.
Secondary Endpoints:
-Other transcriptome changes between week 1 and week 4.
Tertiary Endpoints:
- To make connections with existing genetics and metabolomics data with transcriptomics.
- Stool microbiome studies
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver biopsy | – | Diagnostic Test: Liver biopsyAll participants in the study will undergo liver biopsies |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with alcohol use disorder, currently under inpatient treatment at the NIH.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver biopsyBiopsy of the liver | Diagnostic test | Liver biopsy |
Primary outcome
Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.
Time frame: November 2029
Analysis of liver biopsies
1 secondary outcome
Other transcriptome changes between week 1 and week 4 of alcohol cessation
Time frame: November 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theo Heller, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sawsan Fathma, M.D. ((301) 451-1273, sawsan.fathma@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation. (time frame: November 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.