FLINC: Fatty Liver Disease in Nordic Countries

• Sponsor: Copenhagen University Hospital, Hvidovre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04340817
• Collaborator: (none)
• Enrollment: 634
• Location: 1
• Anticipated Duration (Months): 110
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Diagnostic Test: Proteomics; Diagnostic Test: Transcriptomics; Genetic: Genomics

Study Design

• Study Type: Observational
• Anticipated Enrollment: 634 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fatty Liver Disease in Nordic Countries (FLINC): a Prospective Cohort Study
• Actual Study Start Date: Sep 1, 2017
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Nov 1, 2026

Outcome Measures

Primary Outcome Measures

1. Fibrosis [5 years]

   Number of participants with fibrosis proression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastrounit, Copenhagen University Hospital Hvidovre	Hvidovre	Capital Region Denmark	Denmark	2650

Sponsors and Collaborators

• Copenhagen University Hospital, Hvidovre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lise Gluud, Professor, Copenhagen University Hospital, Hvidovre
• ClinicalTrials.gov Identifier: NCT04340817
• Other Study ID Numbers: Flinc07042020
• First Posted: Apr 10, 2020
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Apr 13, 2020