Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559878
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALPHA
Brief 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-OHBAcAc in humans
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-OHBAcAc in humans
Detailed Description:
In this study we investigate the effects of ethanol and lipids on hepatic mitochondrial metabolism in healthy volunteers
At first visit an informed consent will be obtained followed by assessment of inclusionexclusion criteria Participants fulfilling the criteria will be enrolled in the study Body composition will be determined with bioelectrical impedance
At second visit hepatic lipid content will be measured with magnetic resonance spectroscopy
Participants will be given in random order on three separate visits 3-5
Intravenous infusion of ethanol and normal saline breath alcohol content target and upper limit corresponding to 06 per mil in blood
Intravenous infusions of lipid emulsion heparin and normal saline
Intravenous infusion of normal saline
On study visits participant will drink a tracer dose of 13C-alpha-ketoisocaproate and L-Leucine Breath samples are collected at different time points for determination of 13C enrichment of CO2 Furthermore arterialized blood samples are taken during study visits to obtain beta-hydroxybutyrate to acetoacetate ratios b-OHBAcAc at different timepoints
Whole-body oxidation of lipids carbohydrates and protein will be determined using indirect calorimetry
At first visit an informed consent will be obtained followed by assessment of inclusionexclusion criteria Participants fulfilling the criteria will be enrolled in the study Body composition will be determined with bioelectrical impedance
At second visit hepatic lipid content will be measured with magnetic resonance spectroscopy
Participants will be given in random order on three separate visits 3-5
Intravenous infusion of ethanol and normal saline breath alcohol content target and upper limit corresponding to 06 per mil in blood
Intravenous infusions of lipid emulsion heparin and normal saline
Intravenous infusion of normal saline
On study visits participant will drink a tracer dose of 13C-alpha-ketoisocaproate and L-Leucine Breath samples are collected at different time points for determination of 13C enrichment of CO2 Furthermore arterialized blood samples are taken during study visits to obtain beta-hydroxybutyrate to acetoacetate ratios b-OHBAcAc at different timepoints
Whole-body oxidation of lipids carbohydrates and protein will be determined using indirect calorimetry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None