NCT03535142

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
145mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Aug 2018Apr 2038

First Submitted

Initial submission to the registry

May 1, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
16.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2035

Expected
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2038

Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

16.8 years

First QC Date

May 1, 2018

Last Update Submit

March 3, 2025

Conditions

Non-Alcoholic Fatty Liver DiseaseMetabolic EncephalopathyObesity, MorbidNon-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • Number of participants who will die during the follow up period in case and control group

    Difference in mortality between cases and controls with various NAFLD severity on biopsy.

    10 years follow up after inclusion

Secondary Outcomes (4)

  • Number of participant who will experience progressive fatty liver disease in case and control group

    10 years follow up after inclusion

  • Change in continuous reaction time measurement after bariatric surgery

    10 years follow up after inclusion

  • Change in EEG after bariatric surgery

    24 months after surgery

  • Change in intelligence quotient after bariatric surgery

    24 months efter surgery

Study Arms (2)

Intervention

EXPERIMENTAL

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

Procedure: Bariatric surgery

Control

NO INTERVENTION

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

Interventions

Bariatric surgeryPROCEDURE

Roux en y gastric bypass or gastric sleeve operation

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Active viral hepatitis
  • Not willing or able to consent
  • Contraindications to liver biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Southwest Jutland

Esbjerg, 6700, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40677693DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseBrain Diseases, MetabolicObesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Mette M Lauridsen, MD, PhD

    Esbjerg Hospital - University Hospital of Southern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette M Lauridsen, MD PhD

CONTACT

4579182000mette.enok.munk.lauridsen@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 24, 2018

Study Start

August 15, 2018

Primary Completion (Estimated)

June 1, 2035

Study Completion (Estimated)

April 1, 2038

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)