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The Franciscus Obesity NASH Study — FONS  

Obesity, Morbid Clinical Trial

Official title:
The Franciscus Obesity NASH Study

Clinical Trial 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.

Clinical Trial 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 sugery), liver steatosis and elasticity will be evaluate using Fibroscan. For those with an elevated liver fibrosis measurement (TE ≥7.2 kPa with M probe or ≥7.95 kPa with XL probe), a laparoscopic liver biopsy will be performed during surgery. Patients will undergo gastric sleeve resection, Roux-n-Y gastric bypass or gastric minibypass. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05499949
Study type Observational [Patient Registry]
Source Franciscus Gasthuis
Contact Willy Theel, MSc
Phone +31.10461755
Email w.theel@franciscus.nl
Status Not yet recruiting
Phase
Start date September 1, 2022
Completion date January 1, 2029
View Details
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