MedTrace Logo

Elucidating Hepatic Metabolism in Non-alcoholic Fatty Liver Disease

NCT06942312 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-04-24

No results posted yet for this study

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)?

Conditions

  • Non-alcoholic Fatty Liver Disease (NAFLD)

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

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Panu K. Luukkonen, MD, PhD · University of Helsinki

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06942312 on ClinicalTrials.gov