Bariatric Surgery vs. Lifestyle Modification for NASH (BeLEANeR)

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

NASH - Nonalcoholic Steatohepatitis

Treatments

Procedure: Bariatric Surgery

Behavioral: Lifestyle modification

Study type

Interventional

Funder types

Other

Identifiers

NCT04298736

2019-0780 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Bariatric Surgery

Experimental group

Description:

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

Treatment:

Procedure: Bariatric Surgery

Lifestyle Modification

Active Comparator group

Description:

Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity.

Treatment:

Behavioral: Lifestyle modification