Prognostic Significance of Fatty Liver Disease in Bariatric Patients

NCT ID: NCT03535142

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2038-04-01

Brief Summary

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Prospective non-randomized intervention case control study on patients with a BMI \> 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.

Detailed Description

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Conditions

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Non-Alcoholic Fatty Liver Disease Metabolic Encephalopathy Obesity, Morbid Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation).

Group Type EXPERIMENTAL

Bariatric surgery

Intervention Type PROCEDURE

Roux en y gastric bypass or gastric sleeve operation

Control

Age, BMI and co-morbidity matched group who do not undergo surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bariatric surgery

Roux en y gastric bypass or gastric sleeve operation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* BMI \>35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
* Able to give written informed consent.


* Age \> 18 years
* BMI \>35 kg/m2 with no wish to undergo bariatric surgery.
* Able to give written informed consent.

Exclusion Criteria

* Active viral hepatitis
* Not willing or able to consent
* Contraindications to liver biopsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Esbjerg University Hospital of South-West Jutland

UNKNOWN

Sponsor Role collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Mette Munk Lauridsen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette M Lauridsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Esbjerg Hospital - University Hospital of Southern Denmark

Locations

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Hospital of Southwest Jutland

Esbjerg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mette M Lauridsen, MD PhD

Role: CONTACT

4579182000

Facility Contacts

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Mette Lauridsen, Postdoc

Role: primary

References

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Wernberg CW, Indira Chandran V, Lauridsen MM, Skytthe MK, Hansen CD, Hansen JK, Gronkjaer LL, Jacobsen BG, Di Caterino T, Detlefsen S, Thiele M, Guiliani AM, Villesen IF, Leeming DJ, Karsdal M, Graversen JH, Krag A. Ability of soluble TREM2 and PRO-C3 as biomarkers to predict changes in MASLD activity. JHEP Rep. 2025 Apr 22;7(8):101432. doi: 10.1016/j.jhepr.2025.101432. eCollection 2025 Aug.

Reference Type DERIVED
PMID: 40677693 (View on PubMed)

Other Identifiers

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S-20170210

Identifier Type: -

Identifier Source: org_study_id

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