Actively Recruiting
Vertical Sleeve Gastrectomy and Lifestyle Modification for Treating Non-Alcoholic Steatohepatitis in Adults with BMI 35-60 kg/m2
Led by University of Minnesota · Updated on 2026-05-29
48
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate treatments for Non-Alcoholic Steatohepatitis (NASH) in adults aged 30 to 70 years with a body mass index (BMI) of 35 to 60 kg/m2. The study compares two approaches: lifestyle modification alone, and vertical sleeve gastrectomy (VSG) combined with lifestyle modification. The goal is to assess whether participants can be recruited, randomized, and retained while undergoing invasive and non-invasive tests to measure liver inflammation and fibrosis. The trial also seeks to identify which approach better reduces liver damage scores after 12 months and to gather data supporting a larger, longer-term trial. Participants will be randomly assigned to either the lifestyle modification group or the VSG plus lifestyle group. VSG involves laparoscopic surgery removing part of the stomach, followed by lifestyle counseling. Lifestyle modification includes counseling sessions designed to promote weight loss and increase moderate physical activity, with calorie targets based on body weight. The study includes an initial 7-day low-calorie diet before randomization, and participants will be followed regularly over 12 months with visits to hepatologists and surgeons. Blood tests, urine samples, liver biopsies, and MRI scans will be performed to monitor liver health and treatment effects. Participants will attend weekly lifestyle counseling sessions initially, decreasing in frequency over the year. Vital signs, blood tests including liver function and metabolic panels, and urine samples will be collected at scheduled visits. Liver biopsies will be done at the start and at 12 months, with options for alternative biopsy methods if needed. MRI and serum tests will assess liver fat and stiffness. The study also plans to collect stool and liver tissue samples for further analysis. After 12 months, participants will leave the study but continue usual medical care. The trial aims to provide preliminary data to support longer follow-up over five years to evaluate lasting treatment effects.
CONDITIONS
Brief 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 NAS score of 4 or higher including ballooning score of at least 1.
- Or diagnosed with type 2 diabetes or prediabetes with HbA1c less than 9%.
- Body Mass Index between 35.0 and 60.0 kg/m2 at eligibility visit.
- Willing to accept random assignment to either treatment group.
- Must have insurance covering obesity-related treatments and surgery complications.
- Evidence of liver fat on baseline MRI.
- Suitable for liver biopsy.
- Willing to follow study protocol and complete run-in period.
- Able to provide written informed consent.
- English speaking.
You will not qualify if you...
- Cardiovascular event within past six months.
- Current congestive heart failure, angina, or symptomatic peripheral vascular disease.
- Pulmonary embolus or thrombophlebitis in past six months.
- Cancer except basal cell skin cancer or cancer in situ unless disease-free for five years.
- Significant anemia or history of blood clotting disorders.
- Serum creatinine over 1.8 mg/dL.
- Elevated liver enzymes or bilirubin beyond specified limits.
- Alcohol intake more than one drink or over 20 grams per day.
- History of stomach, bile duct, pancreatic, spleen, or colon surgery.
- Gastric or duodenal ulcer within past six months.
- History of intra-abdominal infection except uncomplicated appendicitis or diverticulitis over six months ago.
- Previous organ transplant.
- HIV positive, active tuberculosis, malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
- Pregnant, nursing, or planning pregnancy within two years.
- History of alcohol, drug, or opioid dependency in past five years.
- Active psychosocial or psychiatric issues likely to interfere with protocol adherence.
- High depression score on CES-D questionnaire.
- Chronic or debilitating diseases making protocol adherence difficult.
- Low serum c-peptide below 1.0 ng/ml post meal.
- History of esophagitis, Barrett's esophagus, or swallowing difficulties.
- Fibrosis score greater than 3.
- Use of the drug Rezdiffra (resmetirom).
- Other exclusions as determined by physician or eligibility committee.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 visits including seminar and eligibility review
Duration - 2 weeks
Participants keep a food and exercise log for two weeks before starting the intervention.
2 visits
Duration - 12 months
Participants are randomized to receive either Vertical Sleeve Gastrectomy plus lifestyle modification or lifestyle modification alone. Participants follow an 800 calorie per day diet for 7 days, then begin their assigned intervention. Lifestyle modification counseling is provided weekly for 6 months, bi-weekly for months 7 to 9, and monthly up to one year. Surgical participants begin lifestyle modification immediately after surgery without calorie limits for 6 months.
Visits at 1 week, 4 weeks, 12 weeks, 6 months, and 12 months with weekly to monthly lifestyle counseling sessions
Duration - At 12 months
At 12 months, participants undergo repeat liver biopsy, MRI, serum marker assessments, and urine sample collection. Participants exit the study and continue usual care.
1 visit for biopsy and assessments
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
Actively Recruiting
3
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
S
Shannon Jannatpour, MS
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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