Bariatric Surgery vs. Lifestyle Modification for NASH | NCT04298736

Studies
Bariatric Surgery vs. Lifestyle Modification for NASH

NCT04298736

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Unknown status

Last Update Posted

Mar 6, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

Bariatric Surgery
Lifestyle modification

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2020Actual

Primary Completion Date

Mar 20, 2022Estimated

Completion Date

Mar 20, 2022Estimated

First Submitted Date

Mar 4, 2020

First Submission Date that Met QC Criteria

Mar 4, 2020

First Posted Date

Mar 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2020

Last Update Posted Date

Mar 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric Surgery	Experimental	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
Lifestyle Modification	Active Comparator	Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity.	Behavioral: Lifestyle modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bariatric Surgery	Procedure	laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy	Bariatric Surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guilherme S Mazzini, MD, PhD	Contact	+55(51)981364873		guimazzini@gmail.com

Overall Officials

Name	Affiliation	Role
Guilherme S Mazzini, MD, PhD	Hospital de Clínicas de Porto Alegre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre	Recruiting	Porto Alegre	Rio Grande do Sul	90035-903	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided