NASH - Nonalcoholic Steatohepatitis
Conditions
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
Interventions
PROCEDUREBariatric Surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
BEHAVIORALLifestyle modification
guided low-calorie diet and physical activity.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded pathologist
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NASH resolution | 12 months | NASH resolution evaluated by liver biopsy |
Countries
Brazil
Contacts
Primary ContactGuilherme S Mazzini, MD, PhD
Outcome results
None listed