The Franciscus Obesity NASH Study

N/AActive Not RecruitingNCT05499949

Franciscus Gasthuis300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

NAFLD NASH - Nonalcoholic Steatohepatitis Obesity, Morbid

Interventions

NASH screeningDIAGNOSTIC_TEST

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

Cardiac dysfunction screeningDIAGNOSTIC_TEST

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

Liver biopsyDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants must fulfil all of the inclusion criteria (unless otherwise specified) for enrolment in the study. 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.

Locations (1)

Franciscus Gasthuis

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

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

Transient elastography is a non invasive test evaluating liver steatosis

Time frame: baseline (enrolment) and 5 years after bariatric surgery

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

Transient elastography is a non invasive test evaluating liver fibrosis

Time frame: baseline (enrolment) and 5 years after bariatric surgery

Secondary Outcomes

Change from baseline in liver steatosis (in decibel/meter) after lifestyle intervention

Transient elastography is a non invasive test evaluating liver steatosis

Time frame: baseline (enrolment) and 3 months later

Change from baseline in liver fibrosis (in kilopascal) after lifestyle intervention

Transient elastography is a non invasive test evaluating liver fibrosis

Time frame: baseline (enrolment) and 3 months later

Change from baseline in liver steatosis (in decibel/meter) 1 year after bariatric surgery

Transient elastography is a non invasive test evaluating liver steatosis

Time frame: baseline (enrolment) and 1 year after bariatric surgery

Change from baseline in liver fibrosis (in kilopascal) 1 year after bariatric surgery

Transient elastography is a non invasive test evaluating liver fibrosis

Time frame: baseline (enrolment) and 1 year after bariatric surgery

Change from baseline in liver steatosis (in decibel/meter) 3 years after bariatric surgery

Data from ClinicalTrials.gov

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