The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² \> BMI ≥ 30 kg/m²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Lifestyle habits (caloric intake and exercise) + pedometer
Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy
Hôpital Claude Huriez, CHRU
Lille, France
RECRUITINGRate of disappearance of NASH without worsening of fibrosis grade
Diagnosis of NASH on the liver biopsy
Time frame: at 60 weeks after randomization
Change in the NAS (Nafld Activity Score) score
NAS is a histological score established on the liver biopsy. The NAS ranges form 0 to 8. 8 is associated with the highest severity.
Time frame: at 60 weeks after randomization
Percentage of patients achieving at least a 2 point improvement in the NAS (≥2 points) without worsening of fibrosis grade
NAS established on the liver biopsy
Time frame: at 60 weeks after randomization
Change in the Brunt fibrosis score,
Brunt fibrosis is a histological score ranges from 0 to 4. The Brunt fibrosis score is established on the liver biopsy. It is the recommended score for the evaluation of fibrosis in NASH and NAFLD. On the scale, "0" is an absence of fibrosis, whereas "4" matches with cirrhosis.
Time frame: at 60 weeks after randomization
Change in the Metavir score
METAVIR fibrosis score is established on the liver biopsy. METAVIR fibrosis is a histological score ranges from 0 to 4. This score is more discriminant than the Brunt score for the severe form of fibrosis that are included in this study.On the scale, "0" is an absence of fibrosis, whereas "4" matches with cirrhosis.
Time frame: at 60 weeks after randomization
Change in the fibrosis area
computerized morphometry analysis of fibrosis area
Time frame: at 60 weeks after randomization
Change in the SF-36 quality of life score.
SF-36 quality of life score
Time frame: at 60 weeks after randomization
Percentage of patients with at least one of the following complications
complications: infection, thromboembolic complications, haemorrhage, rhabdomyolysis, hepatic decompensation and death
Time frame: through study completion
Percentage of patient achieving 5 and 10% of weight loss from randomization to end of treatment.
Weight
Time frame: at 60 weeks after randomization
Change in aspartate transaminase (AST)
AST is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in Alanine transaminase (ALT)
ALT is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in total bilirubin
Total bilirubin is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in GGT
GGT (gamma glutamyl transferase) is a liver enzyme, used for the biological liver test evaluation. .
Time frame: at 60 weeks after randomization
Change in ALP
Alkalin Phosphatase is a liver enzyme, used for the biological liver test evaluation.
Time frame: at 60 weeks after randomization
Change in INR (International Normalized Ratio)
INR represents coagulation but also liver hepatocellular function.
Time frame: at 60 weeks after randomization
Change in Albumin
Albumin is used a marker of nutrition and hepatocellular function
Time frame: at 60 weeks after randomization
Change in metabolic profile assessed by HOMA score
HOMA is a score (scale) evaluating insulin resistance.
Time frame: at 60 weeks after randomization
Change in Fasting glucose
fasting glucose is a marker of diabetes and insulin resistance
Time frame: at 60 weeks after randomization
Change in Glycated haemoglobin
glycated haemoglobin is a surrogate marker for diabetes management and outcome.
Time frame: at 60 weeks after randomization
Change in HDL cholesterol
HDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization
Change in serum triglycerides
serum triglycerides is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization
Change in LDL cholesterol
LDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization
Change in total cholesterol.
total cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Time frame: at 60 weeks after randomization
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