The Franciscus Obesity NASH Study

NCT05499949 | Active Not Recruiting

• 1 other identifier: FONS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transient elastography; Bariatric surgery

Outcome Measures

Primary Outcomes (2)

• Change from baseline in liver steatosis (in decibel/meter) 5 years after bariatric surgery

  Transient elastography is a non invasive test evaluating liver steatosis

  baseline (enrolment) and 5 years after bariatric surgery

• Change from baseline in liver fibrosis (in kilopascal) 5 years after bariatric surgery

  Transient elastography is a non invasive test evaluating liver fibrosis

  baseline (enrolment) and 5 years after bariatric surgery

Secondary Outcomes (18)

• Change from baseline in liver steatosis (in decibel/meter) after lifestyle intervention

  baseline (enrolment) and 3 months later

• Change from baseline in liver fibrosis (in kilopascal) after lifestyle intervention

  baseline (enrolment) and 3 months later

• Change from baseline in liver steatosis (in decibel/meter) 1 year after bariatric surgery

  baseline (enrolment) and 1 year after bariatric surgery

• Change from baseline in liver fibrosis (in kilopascal) 1 year after bariatric surgery

  baseline (enrolment) and 1 year after bariatric surgery

• Change from baseline in liver steatosis (in decibel/meter) 3 years after bariatric surgery

  baseline (enrolment) and 3 years after bariatric surgery

Study Arms (1)

FONS group

Patients with morbid obesity enrolled for bariatric surgery in the Franciscus Gasthuis, Rotterdam, the Netherland

Diagnostic Test: NASH screening; Diagnostic Test: Cardiac dysfunction screening; Diagnostic Test: Liver biopsy

Interventions

NASH screening DIAGNOSTIC_TEST

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

FONS group

Cardiac dysfunction screening DIAGNOSTIC_TEST

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

FONS group

Liver biopsy DIAGNOSTIC_TEST

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.

FONS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with morbid obesity enrolled for bariatric surgery at the Franciscus Gasthuis, Rotterdam, the Netherlands.

You may qualify if:

• Participants must fulfil the criteria of the International Federation for the Surgery of Obesity (IFSO) at screening.
• Participants must be able to understand the nature of the study and written informed consent must be obtained before any study specific interventions are performed.
• The cardiac function of a subset group of 30 subjects aged 35 years and older with low transient elastography measurements (≤F1) and no known cardiac disease, hypertension or diabetes mellitus will be compared with a similar number of patients with high transient elastography measurements (≥F3) and no known cardiac disease, hypertension or diabetes mellitus. These patients will be consecutively included.
• The investigators will perform a liver biopsy during endoscopic bariatric surgery in the patients with an elevated transient elastography measurement (≥F2; suggesting fibrosis and therefore the presence of NASH) in order to correlate the histological diagnosis to the clinical diagnosis based on elastography. In those patients in whom the diagnosis of NASH is confirmed by histology, more detailed follow up in a separate program at the department of gastroenterology is indicated according to the current guidelines.

You may not qualify if:

• Patients who meet any of the following criteria at screening (unless otherwise specified) will be excluded from the study:
• Participants younger than 18 years or older than 65 years
• Participants with an established diagnosis of liver pathology like, but not limited to:
• Hepatitis B
• Hepatitis C
• Autoimmune hepatitis
• Wilson's disease
• Hemochromatosis
• Primary biliary cholangitis
• Primary sclerosing cholangitis
• Alcoholic liver disease
• Histologically documented liver cirrhosis (fibrosis stage F4), at screening or in a historical biopsy.
• Participants with active HIV infection and/or treatment.
• Participants with diagnosed malignancies with or without active treatment.
• Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient's safety or ability to complete the study.

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Amsterdam UMC: collaborator
• Erasmus Medical Center: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Franciscus Gasthuis

Rotterdam, South Holland, 3045PM, Netherlands

Location

Related Publications (1)

• Theel WB, Boxma-de Klerk BM, Dirksmeier-Harinck F, van Rossum EF, Kanhai DA, Apers JA, van Dalen BM, De Knegt RJ, Neecke B, van der Zwan EM, Grobbee DE, Hankemeier T, Wiebolt J, Castro Cabezas M. Effect of bariatric surgery on NAFLD/NASH: a single-centre observational prospective cohort study. BMJ Open. 2023 Jul 3;13(7):e070431. doi: 10.1136/bmjopen-2022-070431.

  PMID: 37400234 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Feces

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity, Morbid

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)