Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
University of Minnesota
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.
Description
The pilot study proposed in this protocol will determine whether patients with a BMI of 35-60 kg/m2 will consent to liver biopsy, accept randomization to VSG, participate in lifestyle modification for a one-year period and consent to a paired liver biopsy at 12 months. Candidates will be biopsied with 48 randomizations within the first year yielding 20 (including dropouts) participants/group. This should be sufficient to further estimate meaningful differences in liver histology given the estimated weight loss of lifestyle modification with and without VSG and a correlation of percent weight l…
Eligibility
- Age range
- 30–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 30 to 70 years at eligibility visit. * At least one of the following: * Diagnosed with NASH with a total NAS ≥ 4 including a ballooning score of at least 1 * Diagnosed with T2DM or prediabetes, HbA1c\< 9% * Body Mass Index (BMI): 35.0-60.0 kg/m2 at eligibility visit. * Willingness to accept random assignment to either treatment group. * All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study * Evidence of liver fat present in the baseline M…
Interventions
- ProcedureVertical Sleeve Gastrectomy
Surgical Procedure: Vertical Sleeve Gastrectomy
- BehavioralLifestyle Modification Counseling
Behavioral Intervention: Lifestyle Modification Counseling
Locations (4)
- University of San FransiscoSan Francisco, California
- Pennington Biomedical Research CenterBaton Rouge, Louisiana
- Minneapolis VA Medical CenterMinneapolis, Minnesota
- University of MinnesotaMinneapolis, Minnesota