NCT03583437

Hepatic and Cardiac Metabolic Flexibility in Obese With NAFLD.

Completed NA Last updated 24 May 2022

What this trial tests

NA trial testing Exercise in NAFLD - Nonalcoholic Fatty Liver Disease in 17 participants. Completed in 23 May 2022.

Timeline

3 September 2018

Primary endpoint
7 September 2020

23 May 2022

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	17
Start date	3 September 2018
Primary completion	7 September 2020
Estimated completion	23 May 2022
Sites	1 location across Denmark

Drugs / interventions tested

• Exercise

Conditions studied

• NAFLD - Nonalcoholic Fatty Liver Disease — all drugs for NAFLD - Nonalcoholic Fatty Liver Disease →

Sponsor

University of Aarhus

Who can join

Adults 40 to 70, any sex, with NAFLD - Nonalcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac involvement and the progression from NAFLD to NASH are poorly understood but must include altered cardiac and intrahepatic lipid handling. In collaboration with renowned research groups from Oxford, Mayo Clinic and Copenhagen investigators plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with NAFLD and NASH and the relationship with heart function. In addition, the investigators will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. Investigators will address these questions using innovative tracer techniques (11Cpalmitate, 11C acetate, 18FDG glucose PET tracers and TG tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as NMR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. Effects of acute exercise will be assessed. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism and to assess the effect of exercise on both hepatic, cardiac and adipose and skeletal muscle lipid and substrate utilisation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.