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Prognostic Significance of Fatty Liver Disease in Bariatric Patients

NCT03535142 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-03-05

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Bariatric surgery

Roux en y gastric bypass or gastric sleeve operation

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Esbjerg University Hospital of South-West Jutland

    collaborator UNKNOWN

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Principal Investigators

  • Mette M Lauridsen, MD, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2035-06-01
Completion
2038-04-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535142 on ClinicalTrials.gov