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NCT04298736 Clinical Trial

Bariatric Surgery vs. Lifestyle Modification for NASH

NASH - Nonalcoholic Steatohepatitis Clinical Trial

— BeLEANeR  

Official title:
Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04298736
Other study ID # 2019-0780
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 19, 2020
Est. completion date March 20, 2022

Study information
Verified date March 2020
Source Hospital de Clinicas de Porto Alegre
Contact Guilherme S Mazzini, MD, PhD
Phone +55(51)981364873
Email guimazzini@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 20, 2022
Est. primary completion date March 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Procedure:
• Bariatric Surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
Behavioral:
• Lifestyle modification
guided low-calorie diet and physical activity.

Locations
Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre RS

Sponsors (1)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary NASH resolution NASH resolution evaluated by liver biopsy 12 months
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