The Franciscus Obesity NASH Study

NCT ID: NCT05499949

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2029-09-01

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.

Detailed Description

After being informed about the study and potential risks, 300 eligible patients will be included.

All participants will undergo lifestyle intervention before bariatric surgery. Extensive cardiometabolic analyses will be carried out. At 5 different moments (twice before and 3 times after bariatric surgery), liver steatosis and elasticity will be evaluate using Fibroscan. For those with an elevated liver fibrosis measurement (TE ≥7.2 kilopascal with M probe or ≥7.95 kilopascal with extra large probe), a laparoscopic liver biopsy will be performed during surgery. Patients will undergo gastric sleeve resection, Roux-n-Y gastric bypass or gastric minibypass.

Conditions

NAFLD; NASH - Nonalcoholic Steatohepatitis; Obesity, Morbid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

FONS group

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

NASH screening

Intervention Type: DIAGNOSTIC_TEST

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

Cardiac dysfunction screening

Intervention Type: DIAGNOSTIC_TEST

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

Liver biopsy

Intervention Type: 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.

Interventions

NASH screening

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

Intervention Type: DIAGNOSTIC_TEST

Cardiac dysfunction screening

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Participants must fulfil the criteria of the International Federation for the Surgery of Obesity (IFSO) at screening.

2. 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.

Exclusion Criteria

Patients who meet any of the following criteria at screening (unless otherwise specified) will be excluded from the study:

1. Participants younger than 18 years or older than 65 years

2. Participants with an established diagnosis of liver pathology like, but not limited to:

1. Hepatitis B

2. Hepatitis C

3. Autoimmune hepatitis

4. Wilson's disease

5. Hemochromatosis

6. Primary biliary cholangitis

7. Primary sclerosing cholangitis

8. Alcoholic liver disease

3. Histologically documented liver cirrhosis (fibrosis stage F4), at screening or in a historical biopsy.

4. Participants with active HIV infection and/or treatment.

5. Participants with diagnosed malignancies with or without active treatment.

6. 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.

7. The participant does not understand Dutch.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Franciscus Gasthuis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Franciscus Gasthuis

Rotterdam, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 37400234 (View on PubMed)

Other Identifiers

FONS

Identifier Type: -

Identifier Source: org_study_id