NCT03587831

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

Recruiting now NA Last updated 15 June 2025

What this trial tests

NA trial testing Vertical Sleeve Gastrectomy in NASH - Nonalcoholic Steatohepatitis in 48 participants. Currently enrolling.

Timeline

1 July 2021

Primary endpoint
31 May 2026

31 May 2026

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 July 2021
Primary completion	31 May 2026
Estimated completion	31 May 2026
Sites	2 locations across United States

Drugs / interventions tested

• Vertical Sleeve Gastrectomy
• Lifestyle Modification Counseling

Conditions studied

• NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →

Sponsor

University of Minnesota

Who can join

Adults 30 to 70, any sex, with NASH - Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ketogenesis mitigates metabolic dysfunction-associated steatotic liver disease through mechanisms that extend beyond fat oxidation.
   Queathem ED, Stagg DB, Nelson AB, Chaves AB, et al · · 2025 · cited 11× · PMID 40272888 · DOI 10.1172/jci191021