Observational Active not recruiting
NCT05499949 on ClinicalTrials.gov
The Franciscus Obesity NASH Study
- Sponsor: Franciscus Gasthuis
- Collaborators: Amsterdam UMC, Erasmus Medical Center, Leiden University Medical Center
- Enrollment: 300 (Estimated)
- Study start: 2022-09-01 (Actual)
- Primary completion: 2023-09-01 (Actual)
- Study completion: 2029-09-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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
Intervention / Treatment
- Diagnostic Test: NASH screening
- Diagnostic Test: Cardiac dysfunction screening
- Diagnostic Test: Liver biopsy
Primary Outcome Measures
-
Change from baseline in liver steatosis (in decibel/meter) 5 years after bariatric surgery
(baseline (enrolment) and 5 years after bariatric surgery)
Transient elastography is a non invasive test evaluating liver steatosis -
Change from baseline in liver fibrosis (in kilopascal) 5 years after bariatric surgery
(baseline (enrolment) and 5 years after bariatric surgery)
Transient elastography is a non invasive test evaluating liver fibrosis
Countries
Netherlands
Locations and Investigators
- Franciscus Gasthuis, Rotterdam, Netherlands