Bariatric Surgery vs. Lifestyle Modification for NASH

Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial

Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.

Patients with biopsy-proven NASH will be randomized to either bariatric surgery or lifestyle interventions. After 1-year follow-up a liver biopsy will be done to evaluate NASH resolution

Inclusion Criteria:

• BMI between 30 and 45
• with biopsy-proven NASH
• with or without type 2 diabetes
• that fit for bariatric surgery.

Exclusion Criteria:

• borderline NASH ou cirrhosis;
• alcohol consumption (> 20 g/day for men and > 10 g/day for women, for the last 2 years);
• other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis);
• HIV infection;
• unable to provide informed consent;
• previous foregut or bariatric surgery;
• malignancy;
• patients that unfit for bariatric surgery.