Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
NCT ID: NCT06559878
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
12 participants
INTERVENTIONAL
2024-09-01
2027-01-31
Brief Summary
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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?
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Detailed Description
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At first visit, an informed consent will be obtained, followed by assessment of inclusion/exclusion criteria. Participants fulfilling the criteria will be enrolled in the study. Body composition will be determined with bioelectrical impedance.
At second visit hepatic lipid content will be measured with magnetic resonance spectroscopy.
Participants will be given in random order on three separate visits (3-5):
* Intravenous infusion of ethanol and normal saline (breath alcohol content target and upper limit corresponding to 0.6 per mil in blood)
* Intravenous infusions of lipid emulsion, heparin and normal saline
* Intravenous infusion of normal saline
On study visits participant will drink a tracer dose of 13C-alpha-ketoisocaproate and L-Leucine. Breath samples are collected at different time points for determination of 13C enrichment of CO2. Furthermore "arterialized" blood samples are taken during study visits to obtain beta-hydroxybutyrate to acetoacetate ratios (b-OHB/AcAc) at different timepoints.
Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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The order of metabolic visits: 1.Normal saline, 2.Lipid emulsion, 3.Ethanol
13C-α-Ketoisocaproic Acid Breath Test
13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).
Ethanol
6% ethanol soluted in normal saline is given intravenously during one metabolic visit.
Lipid Emulsion
Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.
Normal Saline
Normal saline is given intravenously during one metabolic visit.
The order of metabolic visits: 1. Normal saline, 2. Ethanol, 3. Lipid emulsion
13C-α-Ketoisocaproic Acid Breath Test
13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).
Ethanol
6% ethanol soluted in normal saline is given intravenously during one metabolic visit.
Lipid Emulsion
Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.
Normal Saline
Normal saline is given intravenously during one metabolic visit.
The order of metabolic visits: 1.Lipid emulsion, 2.Normal saline, 3.Ethanol
13C-α-Ketoisocaproic Acid Breath Test
13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).
Ethanol
6% ethanol soluted in normal saline is given intravenously during one metabolic visit.
Lipid Emulsion
Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.
Normal Saline
Normal saline is given intravenously during one metabolic visit.
The order of metabolic visits: 1.Lipid emulsion, 2.Ethanol, 3.Normal saline
13C-α-Ketoisocaproic Acid Breath Test
13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).
Ethanol
6% ethanol soluted in normal saline is given intravenously during one metabolic visit.
Lipid Emulsion
Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.
Normal Saline
Normal saline is given intravenously during one metabolic visit.
The order of metabolic visits: 1. Ethanol, 2. Normal saline, 3. Lipid emulsion
13C-α-Ketoisocaproic Acid Breath Test
13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).
Ethanol
6% ethanol soluted in normal saline is given intravenously during one metabolic visit.
Lipid Emulsion
Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.
Normal Saline
Normal saline is given intravenously during one metabolic visit.
The order of metabolic visits: 1. Ethanol, 2. Lipid emulsion, 3. Normal saline
13C-α-Ketoisocaproic Acid Breath Test
13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).
Ethanol
6% ethanol soluted in normal saline is given intravenously during one metabolic visit.
Lipid Emulsion
Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.
Normal Saline
Normal saline is given intravenously during one metabolic visit.
Interventions
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13C-α-Ketoisocaproic Acid Breath Test
13C-α-Ketoisocaproic acid with L-Leucine soluted in citric acid drink. The solution is administered orally during metabolic visits (3.-5.).
Ethanol
6% ethanol soluted in normal saline is given intravenously during one metabolic visit.
Lipid Emulsion
Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.
Normal Saline
Normal saline is given intravenously during one metabolic visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Age range from 18-75 years.
4. 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.
5. No severe hyperlipidemia or hemophagocytotic syndrome as judged by history and physical examination and standard laboratory tests.
6. No other liver disease except for SLD.
7. No advanced liver disease as judged by history and physical examination and standard laboratory tests.
8. No claustrophobia or metal implants to allow magnetic resonance studies.
9. No pregnancy or lactation in women.
10. No known or anticipated difficulties in cannulation of peripheral veins.
11. 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.
12. No drinking problem based on AUDIT questionnaire.
13. No use of medications interacting with alcohol.
14. No history of heparin induced thrombosytopenia (HIT) or bleeding tendency.
15. No current use of warfarin, direct anticoagulants, or thrombocyte inhibitors.
18 Years
75 Years
ALL
Yes
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Panu Luukkonen
MD, PhD
Principal Investigators
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Panu Luukkonen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Helsinki Central University Hospital
Helsinki, Uusimaa, Finland
Countries
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Other Identifiers
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HUS/8748/2023
Identifier Type: -
Identifier Source: org_study_id
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