Bariatric Surgery vs. Lifestyle Modification for NASH (BeLEANeR)

March 4, 2020 updated by: Hospital de Clinicas de Porto Alegre

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Bariatric Surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
Active Comparator: Lifestyle Modification
Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity.
Behavioral: Lifestyle modification
guided low-calorie diet and physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NASH resolution
Time Frame: 12 months
NASH resolution evaluated by liver biopsy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Guilherme S Mazzini, MD, PhD, Hospital de Clínicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2020

Primary Completion (Anticipated)

March 20, 2022

Study Completion (Anticipated)

March 20, 2022

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0780 (Other Identifier: M D Anderson Cancer Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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