NAFLD - Nonalcoholic Fatty Liver DiseaseNCT03583437
Hepatic and Cardiac Metabolic Flexibility in Obese With NAFLD.
A study testing Exercise in people with NAFLD - Nonalcoholic Fatty Liver Disease, 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 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD - Nonalcoholic Fatty Liver Disease
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Sep 2018to 23 May 2022
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10 obese subject men/women with NAFLD (MR spectroskopi, fibro scanner) (BMI > 30).
- 10 obese subject men/women without NAFLD (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, statins and antihypertensive drugs (non-beta blocker). However, pause 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 6 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
Department of Diabetes and Hormone diseases in Aarhus University Hopital
Skejby, Aarhus N, 8200
About this study
Official title: The Effect of Physical Activity on the Liver and the Heart's Metabolism of Fatty Acids in Obese With and Without NAFLD
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.
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease
- Being tested
- Exercise
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Moderate Intensity Exercise (50 % af VO2max) for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Healthy male volunteers | Experimental | Behavioral: Exercise Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after PET scanning. Receives: Behavioral: Exercise |
| Healthy female volunteers | Experimental | Behavioral: Exercise Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after PET scanning. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of physical activity on the heart's metabolism of fatty acids in obese with and without NAFLD
Primary outcome:
- Fatty acid uptake (mg/kg/min) in the Heart in obese with and without NAFLD
Measured: 2 years
Secondary outcomes (1)
To determine the effect of an acute exercise bout on the improvement of cardiac FA utilization in obese with and without NAFLD.
Fatty acid oxidation (µmol/min) in the Heart in obese with and without NAFLD.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start3 Sep 2018
- Primary completion7 Sep 2020
- Study completion23 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: 1 Healthy male volunteers Behavioral: Exercise Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after PET scanning, Experimental: 2 Healthy female volunteers Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after a PET scanning.
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT03583437
- Sponsor's protocol ID
- jeyanrk
- Status last verified
- May 2022
- First submitted
- 22 May 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
- The Effect of Physical Activity on the Liver and the Heart's Metabolism of Fatty Acids in Obese With and Without NAFLD
- ClinicalTrials.gov ID
- NCT03583437
- Acronym / sponsor ID
- jeyanrk
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 11 Jul 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: 1 Healthy male volunteers Behavioral: Exercise Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after PET scanning, Experimental: 2 Healthy female volunteers Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after a PET scanning.
| Arm | Type | Receives |
|---|---|---|
| Healthy male volunteers | Experimental | Behavioral: ExerciseBehavioral: Exercise Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after PET scanning. |
| Healthy female volunteers | Experimental | Behavioral: ExerciseBehavioral: Exercise Moderate Intensity Exercise (50 % af VO2max) for 90 minutes before and after PET scanning. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 10 obese subject men/women with NAFLD (MR spectroskopi, fibro scanner) (BMI > 30).
- 10 obese subject men/women without NAFLD (MR spectroskopi, fibro scanner) (BMI > 30).
- age between 40-70 years
- Written consent before the start of the study
Key exclusion criteria (9 listed)
- known current disease
- Fixed Medical drug consumption, statins and antihypertensive drugs (non-beta blocker). However, pause 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 6 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseModerate Intensity Exercise (50 % af VO2max) for 90 minutes | Behavioural | Healthy female volunteers, Healthy male volunteers |
Primary outcome
The effect of physical activity on the heart's metabolism of fatty acids in obese with and without NAFLD
Time frame: 2 years
Primary outcome: - Fatty acid uptake (mg/kg/min) in the Heart in obese with and without NAFLD
1 secondary outcome
To determine the effect of an acute exercise bout on the improvement of cardiac FA utilization in obese with and without NAFLD.
Time frame: 2 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?
A study testing Exercise in people with NAFLD - Nonalcoholic Fatty Liver Disease, 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 4 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?
The effect of physical activity on the heart's metabolism of fatty acids in obese with and without NAFLD (time frame: 2 years). 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.