NCT05499949

The Franciscus Obesity NASH Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Franciscus Gasthuis · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2029-09-01
• First posted: 2022-08-12
• Last updated: 2025-08-27

Locations

1 site across 1 country: Netherlands