NCT04298736

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

March 4, 2020

Last Update Submit

March 4, 2020

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • NASH resolution

    NASH resolution evaluated by liver biopsy

    12 months

Study Arms (2)

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

Bariatric SurgeryPROCEDURE

laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy

Bariatric Surgery
Lifestyle modificationBEHAVIORAL

guided low-calorie diet and physical activity.

Lifestyle Modification

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 30 and 45
  • with biopsy-proven NASH
  • with or without type 2 diabetes
  • that fit for bariatric surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Guilherme S Mazzini, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme S Mazzini, MD, PhD

CONTACT

+55(51)981364873guimazzini@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded pathologist
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

February 19, 2020

Primary Completion

March 20, 2022

Study Completion

March 20, 2022

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

BR(1)