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The Franciscus Obesity NASH Study

NCT05499949 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-08-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after bariatric surgery.

In addition, genomics, microbiome and metabolomics analyses will be carried out.

Conditions

  • NAFLD
  • NASH - Nonalcoholic Steatohepatitis
  • Obesity, Morbid

Interventions

DIAGNOSTIC_TEST

NASH screening

Evaluate liver steatosis and elasticity using transient elastography in the FONS group

DIAGNOSTIC_TEST

Cardiac dysfunction screening

Evaluate cardiac dysfunction in 60 patients from the FONS group with transthoracic echocardiography

DIAGNOSTIC_TEST

Liver biopsy

For participants from the FONS group with an elevated liver fibrosis measurement (≥F2) with TE, a laparoscopic liver biopsy will be performed during the bariatric procedure.

Sponsors & Collaborators

  • Amsterdam UMC

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Franciscus Gasthuis

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-01
Completion
2029-09-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

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 NCT05499949 on ClinicalTrials.gov