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ENROLLING BY INVITATION
NCT06942312

Elucidating Hepatic Metabolism in Non-alcoholic Fatty Liver Disease

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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)

DIAGNOSTIC_TEST

Ammonium Chloride

15N-ammonium chloride stable isotope test to estimate ureagenesis (20 mg/kg body weight; oral dose; study duration 390 min)

DIAGNOSTIC_TEST

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)

DIAGNOSTIC_TEST

Deuterated Water

Deuterated water stable isotope test to estimate hepatic de novo lipogenesis and gluconeogenesis (3 g/kg body water; oral dose; duration: overnight)

DIAGNOSTIC_TEST

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