Bariatric Surgery vs. Lifestyle Modification for NASH
Not Applicable
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Behavioral: Lifestyle modificationProcedure: Bariatric Surgery
- 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
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
- Arm && Interventions
Group Intervention Description Lifestyle Modification Lifestyle modification Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity. Bariatric Surgery Bariatric Surgery Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to either laparoscopic Roux-en-Y Gastric Bypass or laparoscopic Sleeve Gastrectomy
- Primary Outcome Measures
Name Time Method NASH resolution 12 months NASH resolution evaluated by liver biopsy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil