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Bariatric Surgery vs. Lifestyle Modification for NASH (BeLEANeR)

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bariatric Surgery
Lifestyle modification
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bariatric Surgery

Lifestyle Modification

Arm 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

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

Outcomes

Primary Outcome Measures

NASH resolution
NASH resolution evaluated by liver biopsy

Secondary Outcome Measures

Full Information

First Posted
March 4, 2020
Last Updated
March 4, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04298736
Brief Title
Bariatric Surgery vs. Lifestyle Modification for NASH
Acronym
BeLEANeR
Official Title
Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
March 20, 2022 (Anticipated)
Study Completion Date
March 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blinded pathologist
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bariatric Surgery
Arm Type
Experimental
Arm 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
Arm Title
Lifestyle Modification
Arm Type
Active Comparator
Arm Description
Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity.
Intervention Type
Procedure
Intervention Name(s)
Bariatric Surgery
Intervention Description
laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
guided low-calorie diet and physical activity.
Primary Outcome Measure Information:
Title
NASH resolution
Description
NASH resolution evaluated by liver biopsy
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guilherme S Mazzini, MD, PhD
Phone
+55(51)981364873
Email
guimazzini@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilherme S Mazzini, MD, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilherme S Mazzini, MD, PhD
Phone
+55(51)981364873
Email
guimazzini@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Bariatric Surgery vs. Lifestyle Modification for NASH

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