Fatty Liver Disease in Nordic Countries (FLINC)

April 9, 2020 updated by: Lise Gluud, Copenhagen University Hospital, Hvidovre

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

634

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Capital Region Denmark
      • Hvidovre, Capital Region Denmark, Denmark, 2650

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The investigators plan to include patients with suspected or verified non-alcoholic fatty liver disease

Description

Inclusion Criteria:

  • Non-alcoholic fatty liver disease and
  • Healthy volunteers

Exclusion Criteria:

  • Other liver diseases than non-alcoholic fatty liver disease
  • Lack of informed consent

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
Fibrosis
Time Frame: 5 years
Number of participants with fibrosis proression
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: Lise L Gluud, MD, Copenhagen University Hospital, Hvidovre, Denmark

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)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

November 1, 2026

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flinc07042020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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