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Vertical Sleeve Gastrectomy and Lifestyle Modification for NASH

This study is looking at two ways to treat Nonalcoholic Steatohepatitis (NASH), a liver condition. It compares Vertical Sleeve Gastrectomy (a surgical procedure to reduce stomach size) combined with lifestyle modification counseling, against lifestyle modification counseling alone. The study wants to see which approach is better at improving your liver health, specifically by looking at changes in your NAFLD Activity Score (NAS) after 12 months. You might be able to join if you are between 30 and 70 years old, have NASH, and a Body Mass Index (BMI) between 35.0 and 60.0 kg/m2. The current status of this study is unclear.

Study design
This study plans to enroll 48 participants who will be randomly assigned to one of two groups: lifestyle modification alone or Vertical Sleeve Gastrectomy with lifestyle modification.
What's involved
Participants will undergo a liver biopsy, participate in lifestyle modification for one year, and have a second liver biopsy at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after entering the trial.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03587831

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

Recruiting
NAAges 30–70InterventionalTreatment
University of Minnesota
~48 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Vertical Sleeve GastrectomyLifestyle Modification Counseling

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Histologic improvements in NAFLD Activity Score (NAS)
Measured over Month 12

Conditions

NASH - Nonalcoholic Steatohepatitis

Explore related trials

Nonalcoholic Steatohepatitis

NCT03587831

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Minneapolis VA Medical Center

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Pennington Biomedical Research Center

    Baton Rouge, Louisianastudy coordinator listed

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • University of San Fransisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sayeed Ikramuddin, M.D., M.H.A. · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Shannon Jannatpour, MS
[email protected]
6126727422
Email the study team

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Eligibility criteria

Inclusion

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 MR images
Suitable for liver biopsy
Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
Written informed consent.
English speaking

Exclusion

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 documented to be disease-free for five years.
Significant anemia (hemoglobin 2.0 g/dL or more below normal range) or history of coagulopathy. (Low range for women would be 10, low range for men would be 11)
Serum creatinine \>1.8 mg/dL.
Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than 2.5x the upper limit of normal. Elevated INR.
Alcohol intake more than one drink or \>20 grams per day
History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
Gastric or duodenal ulcer in the past six months.
History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
Previous organ transplantation.
Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
Currently pregnant or nursing, or planning to become pregnant in the next two years.
History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
A score of 17 or greater on the CES-D questionnaire administered on a typical week for the participant.
Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
Serum c-peptide \<1.0 ng/ml post prandial.
Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus.
Any history of dysphagia.
Fibrosis score \> 3
Use of Rezdiffra (resmetirom).

What this trial measures

  • Histologic improvements in NAFLD Activity Score (NAS)Month 12

    The scale used is NAS - this is the NAFLD (Nonalcoholic Fatty Liver Disease) Activity Score. The NAS was developed to provide a numerical score for patients who most likely have NASH. Accordingly, NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3). NAS scores of 0-2 are largely considered not diagnostic of NASH, scores of 3-4 are often considered not diagnostic, borderline, or potentially positive for NASH. Scores of 5-8 are largely considered diagnostic of NASH. It is expected that the addition of VSG to lifestyle modification will result in more robust histologic improvements in NAFLD Activity Score (NAS) compared to lifestyle modification alone.