Fatty Liver Disease in Nordic Countries | NCT04340817

Studies
Fatty Liver Disease in Nordic Countries

NCT04340817

Sponsor

Copenhagen University Hospital, Hvidovre

Status

Recruiting

Last Update Posted

Apr 13, 2020Actual

Enrollment

634Estimated

Phase

Not provided

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Proteomics
Transcriptomics
Genomics

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Apr 7, 2020

First Submission Date that Met QC Criteria

Apr 9, 2020

First Posted Date

Apr 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2020

Last Update Posted Date

Apr 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lise Gluud, Professor, Copenhagen University Hospital, HvidovrePrincipal Investigator

Lead Sponsor

Copenhagen University Hospital, HvidovreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

634Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Proteomics	Diagnostic Test	Mass-spectometry proteomics
Transcriptomics	Diagnostic Test	Next generation sequencing
Genomics	Genetic	Targeted genetics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fibrosis	Number of participants with fibrosis proression	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise L Gluud, MD	Contact	+45 38623862		lise.lotte.gluud.01@regionh.dk
Mikkel P Werge, MD	Contact	+45 38623862		Mikkel.parsberg.werge@regionh.dk

Overall Officials

Name	Affiliation	Role
Lise L Gluud, MD	Copenhagen University Hospital, Hvidovre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastrounit, Copenhagen University Hospital Hvidovre	Recruiting	Hvidovre	Capital Region Denmark	2650	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016678	Genome

Ancestor Terms

ID	Term
D040342	Genetic Structures
D055614	Genetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided