NAFLD - Nonalcoholic Fatty Liver DiseaseNCT03678727
Effects of Exercise on VLDL-TG Metabolism
An observational study of NAFLD - Nonalcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NAFLD - Nonalcoholic Fatty Liver Disease, NASH - Nonalcoholic Steatohepatitis
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2018to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- • 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
Who cannot join
- 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
Show all 9Show fewer
- Weight over 130 kg
- Cancer patients
- Large intake of medication
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Arhus University Hospital Department of Endocrinology and Internal Medicine
Skejby, Aarhus N, 8200
About this study
Official title: 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.
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of exercise on VLDL-TG metabolism in individuals with NAFL or NASH
- VLDL-TG turnover (µmol/min)
- To evaluate the acute effects of exercise on VLDL-TG secretion and clearance
- To assess the uptake and cellular/intracellular regulation of FFA and VLDL-TG in fat and muscle tissue
Measured: 3 years
Effects of exercise on VLDL-TG metabolism in individuals with NAFL or NASH
LPL-activity (µmol/time)
Measured: 3 years
Secondary outcomes (2)
Compare the acute effects of exercise in individuals with NAFL or NASH
Oxidation of VLDL-TG-FA(µmol/min)
Measured: 3 years
Compare the acute effects of exercise in individuals with NAFL or NASH
FFA turnover (µmol/min)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Dec 2018
- Primary completion10 Nov 2020
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD - Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678727
- Sponsor's protocol ID
- Jeyanproject2
- Status last verified
- May 2022
- First submitted
- 18 Sep 2018
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on VLDL-TG Metabolism in Individuals With NAFL and NASH
- ClinicalTrials.gov ID
- NCT03678727
- Acronym / sponsor ID
- Jeyanproject2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- • 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI > 30).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of exercise on VLDL-TG metabolism in individuals with NAFL or NASH
Time frame: 3 years
* VLDL-TG turnover (µmol/min) * To evaluate the acute effects of exercise on VLDL-TG secretion and clearance * To assess the uptake and cellular/intracellular regulation of FFA and VLDL-TG in fat and muscle tissue
Effects of exercise on VLDL-TG metabolism in individuals with NAFL or NASH
Time frame: 3 years
LPL-activity (µmol/time)
2 secondary outcomes
Compare the acute effects of exercise in individuals with NAFL or NASH
Time frame: 3 years
Compare the acute effects of exercise in individuals with NAFL or NASH
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD - Nonalcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of exercise on VLDL-TG metabolism in individuals with NAFL or NASH (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.