Actively Recruiting
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
Led by University of Minnesota · Updated on 2026-05-08
48
Participants Needed
4
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 30 to 70 years at eligibility visit.
- Diagnosed with NASH with a total NAS 24 2 including a ballooning score of at least 1.
- Diagnosed with type 2 diabetes or prediabetes, HbA1c less than 9%.
- Body Mass Index (BMI) between 35.0 and 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.
- Evidence of liver fat present in the baseline MRI images.
- Suitable for liver biopsy.
- Willingness to comply with the follow-up protocol and successful completion of the run-in.
- Written informed consent.
- English speaking.
You will not qualify if you...
- Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- Pulmonary embolus or thrombophlebitis in the past six months.
- Cancer of any kind (except basal cell skin cancer or cancer in situ) unless disease-free for five years.
- Significant anemia or history of coagulopathy.
- Serum creatinine greater than 1.8 mg/dL.
- Serum total bilirubin greater than upper limit of normal without Gilbert's syndrome, or alkaline phosphatase, ALT, or AST greater than 2.5 times upper limit.
- Alcohol intake more than one drink or over 20 grams per day.
- History of stomach, bile duct, pancreatic surgery, splenectomy, or colon resection.
- Gastric or duodenal ulcer in past six months.
- History of intra-abdominal sepsis except uncomplicated appendicitis or diverticulitis more than six months prior.
- Previous organ transplantation.
- HIV positive, active tuberculosis, malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
- Currently pregnant, nursing, or planning pregnancy in next two years.
- History of alcohol, drug, or opioid dependency in past five years.
- Active psychosocial or psychiatric problems likely to interfere with study adherence.
- CES-D questionnaire score of 17 or greater.
- Chronic or debilitating disease making protocol adherence difficult.
- Serum c-peptide less than 1.0 ng/ml post prandial.
- History of esophagitis or Barrett's changes.
- History of dysphagia.
- Fibrosis score greater than 3.
- Use of Rezdiffra (resmetirom).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of San Fransisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Not Yet Recruiting
3
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Not Yet Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Completed
Research Team
S
Shannon Jannatpour, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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