NCT06942312Enrolling by invitation
Elucidating Hepatic Metabolism in Non-alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational, cross-sectional, case-control clinical study is to investigate the metabolic adaptations underlying the progression of nonalcoholic fatty liver disease (NAFLD), and to test the hypothesis that hepatic mitochondrial reductive stress contributes to progression of NAFLD. The main question it aims to answer is: Do patients with advanced NAFLD compared to patients with mild NAFLD and healthy controls have increased hepatic mitochondrial reductive stress as determined by the ketoisocaproate breath test and by plasma beta-hydroxybutyrate to acetoacetate ratio (b-OHB/AcAc)?
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 14 Mar 2025
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06942312
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 May 2025 to the primary completion date, 31 Dec 2029
- 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
- The following inclusion/ exclusion criteria will be employed:
- 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.
- Participants must be aged between 18-75 years.
- Participants are not allowed to have alcohol consumption of 350 g/week or more in women and 420 g/week or more in men.
- Participants are not allowed to have history of liver disease other than NAFLD as judged by history and physical examination and standard laboratory tests.
- Participants are not allowed to have claustrophobia or metal implants to allow magnetic resonance studies.
- Participants are not allowed to be pregnant or lactating.
- 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.
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.