Status:
ENROLLING_BY_INVITATION
Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Non-alcoholic Fatty Liver Disease NAFLD
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 mitochondria...
Detailed Description
In this study we investigate the effects of ethanol and lipids on hepatic mitochondrial metabolism in healthy volunteers. At first visit, an informed consent will be obtained, followed by assessment ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06559878
Start Date
September 1 2024
End Date
January 31 2027
Last Update
August 19 2024
Active Locations (1)
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1
Helsinki Central University Hospital
Helsinki, Uusimaa, Finland, 00290