Non-alcoholic Fatty Liver DiseaseNCT02488941
Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
An observational study of Non-alcoholic Fatty Liver Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the western world and an important cause of morbidity and mortality including risk of cardiovascular disease. A ruling dogma is that a fatty liver is well-functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with varying degrees of NAFLD
Who may be able to join
- Age ≥ 18
- Hepatic steatosis found on ultrasound
- Clinical indication for liver biopsy (typically persistently elevated alanine transaminase (ALT) levels)
Who cannot join
- Other liver pathology
- Alcohol consumption > 20g/day
- Chronic inflammatory disease, current infection or cancer
- Diabetes mellitus type I, II or HbA1c ≥ 48 mmol/mol (6.5 %)
- Prednisolone treatment within last 8 weeks
- Pregnancy within last 12 months
- Contraindication for MRI
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Hepatology & Gastroenterology
Aarhus, 8000
Marianne Vonsild, +45 7846 3892, marianne.vonsild@clin.au.dk
About this study
Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the western world and an important cause of morbidity and mortality including risk of cardiovascular disease. A ruling dogma is that a fatty liver is well-functioning. Recent studies imply the contrary but quantitative measurements of metabolic liver function have not been systematically investigated in NAFLD.
Objectives: To study and quantify specific metabolic liver functions in varying degrees of NAFLD. Furthermore to map the coagulation system of patients with NAFLD.
Read more
Methods: A human clinical study. Metabolic liver functions are studied by a series of functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT), Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance (FHNC)). Regional liver function evaluated by 2-[18F]fluoro-2-deoxy-D-galactose (FDGal) PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated.
Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD, histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant imbalance in NAFLD.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Liver Function Tests, Blood Coagulation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Liver Function assessed by GEC
Measured: Baseline
Metabolic Liver Function assessed by FHNC
Measured: Baseline
Metabolic Liver Function assessed by ABT
Measured: Baseline
Metabolic Liver Function assessed by ICG-PDR
Measured: Baseline
Regional metabolic liver function evaluated by FDGal PET/CT
100 megabecquerel FDGal is injected intravenously in the beginning of a 20 min PET recording and 3D images of regional metabolic liver function expressed in terms of hepatic metabolic clearance of FDGal is created.
Measured: Baseline
Regional fat infiltration assessed by MRI
Measured: Baseline
Secondary outcomes (4)
Primary hemostasis
Measured: Baseline
Secondary hemostasis
Measured: Baseline
Natural anti-coagulants
Measured: Baseline
Fibrinolysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hendrik Vilstrup, Professor, Study director, Department of Hepatology & Gastroenterology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488941
- Sponsor's protocol ID
- Metabolic liver function NAFLD
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02488941
- Acronym / sponsor ID
- Metabolic liver function NAFLD
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Liver Function Tests, Blood Coagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- 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.
Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the western world and an important cause of morbidity and mortality including risk of cardiovascular disease. A ruling dogma is that a fatty liver is well-functioning. Recent studies imply the contrary but quantitative measurements of metabolic liver function have not been systematically investigated in NAFLD.
Objectives: To study and quantify specific metabolic liver functions in varying degrees of NAFLD. Furthermore to map the coagulation system of patients with NAFLD.
Methods: A human clinical study. Metabolic liver functions are studied by a series of functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT), Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance (FHNC)). Regional liver function evaluated by 2-[18F]fluoro-2-deoxy-D-galactose (FDGal) PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated.
Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD, histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant imbalance in NAFLD.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with varying degrees of NAFLD
Key inclusion criteria (3 listed)
- Age ≥ 18
- Hepatic steatosis found on ultrasound
- Clinical indication for liver biopsy (typically persistently elevated alanine transaminase (ALT) levels)
Key exclusion criteria (7 listed)
- Other liver pathology
- Alcohol consumption > 20g/day
- Chronic inflammatory disease, current infection or cancer
- Diabetes mellitus type I, II or HbA1c ≥ 48 mmol/mol (6.5 %)
- Prednisolone treatment within last 8 weeks
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
Metabolic Liver Function assessed by GEC
Time frame: Baseline
Metabolic Liver Function assessed by FHNC
Time frame: Baseline
Metabolic Liver Function assessed by ABT
Time frame: Baseline
Metabolic Liver Function assessed by ICG-PDR
Time frame: Baseline
Regional metabolic liver function evaluated by FDGal PET/CT
Time frame: Baseline
100 megabecquerel FDGal is injected intravenously in the beginning of a 20 min PET recording and 3D images of regional metabolic liver function expressed in terms of hepatic metabolic clearance of FDGal is created.
Regional fat infiltration assessed by MRI
Time frame: Baseline
4 secondary outcomes
Primary hemostasis
Time frame: Baseline
Secondary hemostasis
Time frame: Baseline
Natural anti-coagulants
Time frame: Baseline
Fibrinolysis
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
Hendrik Vilstrup, Professor study director
Department of Hepatology & Gastroenterology, Aarhus University Hospital
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 Non-alcoholic 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Lykke Eriksen, MD (+45 7846 4076, ple@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Liver Function assessed by GEC (time frame: Baseline). The study lists 6 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 2 Jul 2015.