Status:
UNKNOWN
Bariatric Surgery vs. Lifestyle Modification for NASH
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- BMI between 30 and 45
- with biopsy-proven NASH
- with or without type 2 diabetes
- that fit for bariatric surgery.
Exclusion
- 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.
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04298736
Start Date
February 19 2020
End Date
March 20 2022
Last Update
March 6 2020
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903