Bariatric Surgery Versus Non-alcoholic Steato-hepatitis

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This is a Randomized Controlled multicentre Trial involving the Catholic University (Professor Geltrude Mingrone as PI and Professor Marco Raffaelli as co-PI) The research question in PICOT format (P) - Population: Adults 25 to 65 years of age and BMI ? 30 and ?40 kg/m2 with histological diagnosis o...

This is a Randomized Controlled multicentre Trial involving the Catholic University (Professor Geltrude Mingrone as PI and Professor Marco Raffaelli as co-PI) The research question in PICOT format (P) - Population: Adults 25 to 65 years of age and BMI ? 30 and ?40 kg/m2 with histological diagnosis of NASH. Subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls for the discovery of non-invasive biomarkers. (I) - Intervention: Roux-en-Y Gastric Bypass or Sleeve Gastrectomy, both plus lifestyle counseling. (C) - Comparison: Intensive Lifestyle Modifications. (O) - Outcome: the histological resolution of NASH without worsening of fibrosis at 1 year after the interventions. (T) - Time: One year after the intervention started. 1.3.3.2 Research Goals The primary aim of our study is to assess the effects of bariatric-metabolic surgery or ILM on NASH at 1 year after the interventions. Secondary aims are to assess the safety of bariatric surgery and the improvement of liver fibrosis, CVD, insulin sensitivity, T2DM, lipoprotein profile, NASH markers and fecal microbiota at 1 year and the follow up of NASH markers up to 2 years, and to obtain a non-invasive score systems to make diagnosis of NASH. Research outcomes The primary outcome is the histological resolution of NASH without worsening of fibrosis at 1 year after the interventions. The secondary outcomes are : Adverse health events including the need for re-operation Changes in liver fibrosis Changes in glycemic control (only in diabetic patients) Changes in cardiovascular risk score Changes in insulin sensitivity and secretion Changes in food intake Changes in physical activity Changes in quality of life Changes in gut microbiota Changes in body composition: Fat-Free Mass (FFM), Fat Mass (FM). Discovery of non-invasive biomarkers for the diagnosis of non-alcoholic steatohepatitis and liver fibrosis The changes in NASH liver markers will be investigated at 1, and 2 years follow-up.

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