Active — Not RecruitingNot Applicable

The Franciscus Obesity NASH Study

Netherlands300 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: baseline (enrolment) and 5 years after bariatric surgery

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

Timeframe: baseline (enrolment) and 5 years after bariatric surgery

Trial details

NCT IDNCT05499949

SponsorFranciscus Gasthuis

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-01

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