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Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans

NCT06559878 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-19

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate in healthy volunteers the mechanisms by which ethanol and lipids, the two key risk factors of steatotic liver disease (SLD), affect liver mitochondrial metabolism.

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?

Conditions

  • Non-alcoholic Fatty Liver Disease NAFLD

Interventions

DIAGNOSTIC_TEST

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.).

DIETARY_SUPPLEMENT

Ethanol

6% ethanol soluted in normal saline is given intravenously during one metabolic visit.

DIETARY_SUPPLEMENT

Lipid Emulsion

Lipid emulsion, heparin and normal saline are given intravenously during one metabolic visit.

OTHER

Normal Saline

Normal saline is given intravenously during one metabolic visit.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Panu Luukkonen, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-02-28
Completion
2027-01-31

Countries

  • Finland

Study Locations

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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 NCT06559878 on ClinicalTrials.gov