Bariatric Surgery vs. Lifestyle Modification for NASH

Not Applicable

• Conditions: NASH - Nonalcoholic Steatohepatitis

• Registration Number: NCT04298736
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-02-19
• Status Verified: 2020-03
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Study First Posted: 2020-03-06
• Last Update Posted: 2020-03-06
• Primary Completion: 2022-03-20
• Study Completion: 2022-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NASH resolution	12 months	NASH resolution evaluated by liver biopsy

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil