Bariatric Surgery vs. Lifestyle Modification for NASH

Hospital de Clinicas de Porto Alegre50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

Bariatric SurgeryPROCEDURE

laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy

Lifestyle modificationBEHAVIORAL

guided low-calorie diet and physical activity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Outcomes

Primary Outcomes

NASH resolution

NASH resolution evaluated by liver biopsy

Time frame: 12 months

Central Contacts

Guilherme S Mazzini, MD, PhD

CONTACT

+55(51)981364873 guimazzini@gmail.com

Data from ClinicalTrials.gov

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