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
Evaluate liver steatosis and elasticity using transient elastography in the FONS group
Evaluate cardiac dysfunction in 60 patients from the FONS group with transthoracic echocardiography
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.
Franciscus Gasthuis
Rotterdam, South Holland, Netherlands
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
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
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Transient elastography is a non invasive test evaluating liver steatosis
Time frame: baseline (enrolment) and 3 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) 3 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver fibrosis
Time frame: baseline (enrolment) and 3 years after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) according to the type of bariatric surgery
To evaluate if the type of bariatric surgery (gastric sleeve resection, Roux-en-Y Gastric bypass, Gastric minibypass) influences the steatosis in patients with morbid obesity, measured 1 and 3 years after bariatric surgery, adjusted for baseline steatosis/elasticity.
Time frame: baseline and 1 and 3 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) according to the type of bariatric surgery
To evaluate if the type of bariatric surgery (gastric sleeve resection, Roux-en-Y Gastric bypass, Gastric minibypass) influences the elasticity in patients with morbid obesity, measured 1 and 3 years after bariatric surgery, adjusted for baseline steatosis/elasticity.
Time frame: baseline and 1 and 3 years after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) according to the genetic profile
To determine if candidate genetic markers (PNPLA3, TM6SF2, MBOAT7, GCKR and HSD17B13) are associated to changes in NAFLD/NASH severity in patients with morbid obesity one year after bariatric surgery.
Time frame: baseline and 1 year after surgery
Change from baseline in liver fibrosis (in kilopascal) according to the genetic profile
To determine if candidate genetic markers (PNPLA3, TM6SF2, MBOAT7, GCKR and HSD17B13) are associated to changes in NAFLD/NASH severity in patients with morbid obesity one year after bariatric surgery.
Time frame: baseline and 1 year after surgery
Change from baseline in liver steatosis (in decibel/meter) according to gender and ethnicities
To determine if liver steatosis differs between gender or ethnicities before bariatric surgery and the changes 1, 3 and 5 years after bariatric surgery
Time frame: baseline and 1, 3 and 5 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) according to gender and ethnicities
To determine if liver elasticity differs between gender or ethnicities before bariatric surgery and the changes 1, 3 and 5 years after bariatric surgery
Time frame: baseline and 1, 3 and 5 years after bariatric surgery
Change from baseline in liver steatosis liver steatosis (in decibel/meter) according to the gut microbiota
To investigate the change in the ratio of Firmicutes/Bacteroides in the distal gut microbiota in patients with morbid obesity with NAFLD/NASH 1 year after bariatric surgery and the effects of these changes on transient elastography measurements.
Time frame: baseline and 1 year after bariatric surgery
Change from baseline in liver steatosis liver fibrosis (in kilopascal) according to the gut microbiota
To investigate the change in the ratio of Firmicutes/Bacteroides in the distal gut microbiota in patients with morbid obesity with NAFLD/NASH 1 year after bariatric surgery and the effects of these changes on transient elastography measurements.
Time frame: baseline and 1 year after bariatric surgery
Association between NAFLD/NASH and vascular dysfunction
To determine if the presence of NAFLD/NASH before bariatric surgery is associated with (subclinical) vascular dysfunction using the carotid intima media thickness and pulse wave velocity
Time frame: baseline
Association between NAFLD/NASH and cardiac dysfunction
To determine if the presence of NAFLD/NASH before bariatric surgery is associated with (subclinical) cardiac dysfunction using transthoracic echocardiography
Time frame: baseline and 1 year after bariatric surgery
Association between change in NAFLD/NASH and change in cardiac dysfunction
To determine if change of liver fibrosis stage is associated to change in cardiac function 1 year after bariatric surgery
Time frame: baseline and 1 year after bariatric surgery
Correlation between histology and transient elastography measurement in a population with morbid obesity
To establish the correlation between histology (liver biopsy) and transient elastography measurement in a population with morbid obesity
Time frame: during surgery