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Elucidating Hepatic Metabolism in Non-alcoholic Fatty Liver Disease
Sponsor: Helsinki University Central Hospital
Summary
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)?
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2025-05-01
Completion Date
2030-12-31
Last Updated
2025-04-24
Healthy Volunteers
Yes
Interventions
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
Locations (1)
Helsinki Central University Hospital
Helsinki, Uusimaa, Finland