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RECRUITING
NCT03587831
NA

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study, a sample size of 20 in each group should offer significant information as to the difference in NAS score reduction between to two groups and achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2021-07-01

Completion Date

2026-05-31

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

PROCEDURE

Vertical Sleeve Gastrectomy

Surgical Procedure: Vertical Sleeve Gastrectomy

BEHAVIORAL

Lifestyle Modification Counseling

Behavioral Intervention: Lifestyle Modification Counseling

Locations (2)

University of San Fransisco

San Francisco, California, United States

University of Minnesota

Minneapolis, Minnesota, United States