Elucidating Hepatic Metabolism in Non-alcoholic Fatty Liver Disease
NCT ID: NCT06942312
Last Updated: 2025-04-24
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
30 participants
OBSERVATIONAL
2025-05-01
2030-12-31
Brief Summary
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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)?
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Detailed Description
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At the first visit, an informed consent will be obtained, followed by assessment of inclusion/exclusion criteria and medical history. Participants fulfilling the criteria will be enrolled in the study. A physical examination will be performed and laboratory test will be taken. Body composition will be determined with bioelectrical impedance and dual-energy x-ray absorptiometry (DEXA).
At the second visit, hepatic lipid content will be measured with magnetic resonance spectroscopy.
At the third visit, participants will pick up containers for overnight urine collection and doses of deuterated water and a standardized meal replacement bar. The fourth visit is a clinical study visit. In a specified order, participants will drink tracer doses of 15NH4Cl, 13C-bicarbonate and 13C-alpha-ketoisocaproate. An oral glucose tolerance test is performed in the end of the study day. Breath samples are collected at different time points for determination of 13C enrichment of CO2. Furthermore, "arterialized" blood samples are taken 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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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Advanced NAFLD
Intrahepatic triglyceride content ≥ 5.56 % as determined by magnetic resonance specroscopy and liver stiffness measurement ≥ 8 kPa using transient elastography (Fibroscan)
Ketoisocaproic acid breath test
13C-alpha-ketoisocaproic acid breath test to estimate hepatic mitochondrial reductive stress (1 mg/kg body weight; oral dose; study duration 390 min)
Ammonium Chloride
15N-ammonium chloride stable isotope test to estimate ureagenesis (20 mg/kg body weight; oral dose; study duration 390 min)
Bicarbonate de sodium
13C-bicarbonate breath test to estimate body bicarbonate pool size and gastric emptying (0.5 mg/kg body weight; oral dose; study duration 390 min)
Deuterated Water
Deuterated water stable isotope test to estimate hepatic de novo lipogenesis and gluconeogenesis (3 g/kg body water; oral dose; duration: overnight)
Oral Glucose Tolerance Test
A standard 2-hour 75-gram oral glucose tolerance test to assess glucose tolerance and whole body metabolism
Mild NAFLD
Intrahepatic triglyceride content ≥ 5.56 % as determined by magnetic resonance specroscopy and liver stiffness measurement \< 8 kPa using transient elastography (Fibroscan)
Ketoisocaproic acid breath test
13C-alpha-ketoisocaproic acid breath test to estimate hepatic mitochondrial reductive stress (1 mg/kg body weight; oral dose; study duration 390 min)
Ammonium Chloride
15N-ammonium chloride stable isotope test to estimate ureagenesis (20 mg/kg body weight; oral dose; study duration 390 min)
Bicarbonate de sodium
13C-bicarbonate breath test to estimate body bicarbonate pool size and gastric emptying (0.5 mg/kg body weight; oral dose; study duration 390 min)
Deuterated Water
Deuterated water stable isotope test to estimate hepatic de novo lipogenesis and gluconeogenesis (3 g/kg body water; oral dose; duration: overnight)
Oral Glucose Tolerance Test
A standard 2-hour 75-gram oral glucose tolerance test to assess glucose tolerance and whole body metabolism
Healthy control
Intrahepatic triglyceride content \< 5.56 % as determined by magnetic resonance specroscopy and liver stiffness measurement \< 8 kPa using transient elastography (Fibroscan)
Ketoisocaproic acid breath test
13C-alpha-ketoisocaproic acid breath test to estimate hepatic mitochondrial reductive stress (1 mg/kg body weight; oral dose; study duration 390 min)
Ammonium Chloride
15N-ammonium chloride stable isotope test to estimate ureagenesis (20 mg/kg body weight; oral dose; study duration 390 min)
Bicarbonate de sodium
13C-bicarbonate breath test to estimate body bicarbonate pool size and gastric emptying (0.5 mg/kg body weight; oral dose; study duration 390 min)
Deuterated Water
Deuterated water stable isotope test to estimate hepatic de novo lipogenesis and gluconeogenesis (3 g/kg body water; oral dose; duration: overnight)
Oral Glucose Tolerance Test
A standard 2-hour 75-gram oral glucose tolerance test to assess glucose tolerance and whole body metabolism
Interventions
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Ketoisocaproic acid breath test
13C-alpha-ketoisocaproic acid breath test to estimate hepatic mitochondrial reductive stress (1 mg/kg body weight; oral dose; study duration 390 min)
Ammonium Chloride
15N-ammonium chloride stable isotope test to estimate ureagenesis (20 mg/kg body weight; oral dose; study duration 390 min)
Bicarbonate de sodium
13C-bicarbonate breath test to estimate body bicarbonate pool size and gastric emptying (0.5 mg/kg body weight; oral dose; study duration 390 min)
Deuterated Water
Deuterated water stable isotope test to estimate hepatic de novo lipogenesis and gluconeogenesis (3 g/kg body water; oral dose; duration: overnight)
Oral Glucose Tolerance Test
A standard 2-hour 75-gram oral glucose tolerance test to assess glucose tolerance and whole body metabolism
Eligibility Criteria
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Exclusion 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. Participants must be aged between 18-75 years.
4. Participants are not allowed to have alcohol consumption of 350 g/week or more in women and 420 g/week or more in men.
5. Participants are not allowed to have history of liver disease other than NAFLD as judged by history and physical examination and standard laboratory tests.
6. Participants are not allowed to have claustrophobia or metal implants to allow magnetic resonance studies.
7. Participants are not allowed to be pregnant or lactating.
8. No known or anticipated difficulties in cannulation of peripheral veins.
9. 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Panu Luukkonen
Principal Investigator
Principal Investigators
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Panu K. Luukkonen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Helsinki
Locations
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Helsinki Central University Hospital
Helsinki, Uusimaa, Finland
Countries
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Other Identifiers
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HUS/176/2025
Identifier Type: -
Identifier Source: org_study_id
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