- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678727
Effects of Exercise on VLDL-TG Metabolism
May 23, 2022 updated by: University of Aarhus
Effects of Exercise on VLDL-TG Metabolism in Individuals With NAFL and NASH
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 NAFL 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 we 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 NAFL and NASH and the relationship with heart function.
In addition, we 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.
We 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 as well as GLP-1 agonist and SGLT-2 inhibitor treatment (alone and in combination) 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 hepatic, adipose and skeletal muscle lipid and substrate utilisation.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus N
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Skejby, Aarhus N, Denmark, 8200
- Arhus University Hospital Department of Endocrinology and Internal Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI > 30). 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI > 30).
• age between 40-70 years Written consent before the start of the study
Description
Inclusion Criteria:
• 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI > 30).
- 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI > 30).
- age between 40-70 years Written consent before the start of the study
Exclusion Criteria:
- known current disease
- Fixed medical drug consumption except antihypertensive drugs and statins. However, pause statins 3 weeks before the examination date
- Blood donation within the last 3 months prior to the study
- Participation in experiments involving radioactive isotopes within the last 3 months
- Alcohol abuse (over 21 items per week for men and 14 for women)
- Smoking
- Weight over 130 kg
- Cancer patients
- Large intake of medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of exercise on VLDL-TG metabolism in individuals with NAFL or NASH
Time Frame: 3 years
|
|
3 years
|
Effects of exercise on VLDL-TG metabolism in individuals with NAFL or NASH
Time Frame: 3 years
|
LPL-activity (µmol/time)
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the acute effects of exercise in individuals with NAFL or NASH
Time Frame: 3 years
|
Oxidation of VLDL-TG-FA(µmol/min)
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3 years
|
Compare the acute effects of exercise in individuals with NAFL or NASH
Time Frame: 3 years
|
FFA turnover (µmol/min)
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
November 10, 2020
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
September 18, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 20, 2018
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jeyanproject2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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