Clinical Trials Directory

Trials / Unknown

UnknownNCT04298736

Bariatric Surgery vs. Lifestyle Modification for NASH

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Hospital de Clinicas de Porto Alegre · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREBariatric Surgerylaparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
BEHAVIORALLifestyle modificationguided low-calorie diet and physical activity.

Timeline

Start date
2020-02-19
Primary completion
2022-03-20
Completion
2022-03-20
First posted
2020-03-06
Last updated
2020-03-06

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04298736. Inclusion in this directory is not an endorsement.