NCT07191561 Hepatic Lipid Metabolism-Alcohol Use Disorder
| NCT ID | NCT07191561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Condition | Alcohol Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-07-26 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2026-07-26 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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,
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.
Contact & Investigator
Theo Heller, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Frequently Asked Questions
Who can join the NCT07191561 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07191561 currently recruiting?
Yes, NCT07191561 is actively recruiting participants. Contact the research team at sawsan.fathma@nih.gov for enrollment information.
Where is the NCT07191561 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07191561 clinical trial?
NCT07191561 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The principal investigator is Theo Heller, M.D. at National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trial plans to enroll 25 participants.