Non-Alcoholic Fatty Liver DiseaseFLINCNCT04340817
Fatty Liver Disease in Nordic Countries
An observational study of Non-Alcoholic Fatty Liver Disease, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Proteomics, Transcriptomics and Genomics
- How many people
- 634 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2017to 1 Nov 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators plan to include patients with suspected or verified non-alcoholic fatty liver disease
Who may be able to join
- Non-alcoholic fatty liver disease and
- Healthy volunteers
Who cannot join
- Other liver diseases than non-alcoholic fatty liver disease
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region Denmark, 2650
Lise L Gluud, MD, +4538621964, lise.lotte.gluud.01@regionh.dk
Mikkel P Werge, MD, +38620411, mikkel.parsberg.werge@regionh.dk
About this study
Official title: Fatty Liver Disease in Nordic Countries (FLINC): a Prospective Cohort Study
A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Proteomics, Transcriptomics, Genomics
- 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.
ProteomicsDiagnostic test
Mass-spectometry proteomics
TranscriptomicsDiagnostic test
Next generation sequencing
GenomicsGenetic
Targeted genetics
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis
Number of participants with fibrosis proression
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Sep 2017
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2026 (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.
- 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
- 634 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise Gluud, Copenhagen University Hospital, Hvidovre
- Investigators
- Lise L Gluud, MD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340817
- Sponsor's protocol ID
- Flinc07042020
- Acronym
- FLINC
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Liver Disease in Nordic Countries (FLINC): a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04340817
- Acronym / sponsor ID
- FLINC / Flinc07042020
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 10 Apr 2020 (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.
A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to include patients with suspected or verified non-alcoholic fatty liver disease
Key inclusion criteria (2 listed)
- Non-alcoholic fatty liver disease and
- Healthy volunteers
Key exclusion criteria (2 listed)
- Other liver diseases than non-alcoholic fatty liver disease
- Lack of informed consent
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 |
|---|---|---|
| ProteomicsMass-spectometry proteomics | Diagnostic test | – |
| TranscriptomicsNext generation sequencing | Diagnostic test | – |
| GenomicsTargeted genetics | Genetic | – |
Primary outcome
Fibrosis
Time frame: 5 years
Number of participants with fibrosis proression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Lise L Gluud, MD principal investigator
Copenhagen University Hospital, Hvidovre
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 Copenhagen University Hospital, Hvidovre 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 2 inclusion and 2 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 13 Apr 2020. 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 Lise L Gluud, MD (+45 38623862, lise.lotte.gluud.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis (time frame: 5 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 13 Apr 2020.