NCT06559878Enrolling by invitation
Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to investigate in healthy volunteers the mechanisms by which ethanol and lipids, the two key risk factors of steatotic liver disease (SLD), affect liver mitochondrial metabolism. The main question it aims to answer is: • Does acute administration of ethanol and lipids increase hepatic mitochondrial reductive stress as determined by orally ingested stable isotope tracer 13C-alpha-ketoisocaproate and by plasma beta-hydroxybutyrate to acetoacetate ratio (b-OHB/AcAc) in humans?
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 12 Aug 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06559878
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 1 Sept 2024 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- Subject must be likely to be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge.
- Age range from 18-75 years.
- No known hypersensitivity to egg, soy, or peanut protein, or to any of the substances of Intralipid 20%, or to any other substance to be administered during the study.
- No severe hyperlipidemia or hemophagocytotic syndrome as judged by history and physical examination and standard laboratory tests.
- No other liver disease except for SLD.
- No advanced liver disease as judged by history and physical examination and standard laboratory tests.
- No claustrophobia or metal implants to allow magnetic resonance studies.
- No pregnancy or lactation in women.
- No known or anticipated difficulties in cannulation of peripheral veins.
- No history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
- No drinking problem based on AUDIT questionnaire.
- No use of medications interacting with alcohol.
- No history of heparin induced thrombosytopenia (HIT) or bleeding tendency.
- No current use of warfarin, direct anticoagulants, or thrombocyte inhibitors.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helsinki Central University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.