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


This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes.  Participants must be 30-70 years old, have a BMI of 35.0-50.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.

I'm interested

Male or Female
18 Years and over
Inclusion Criteria:
Age 30 to 70 years at eligibility visit. Diagnosed with NASH with a total NAS ≥ 4 including a ballooning, or diagnosed with T2DM or prediabetes, HbA1c< 9% Body Mass Index (BMI): 35.0-50.0 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 Expect to live or work within approximately two-hours traveling time from the study clinic for the duration of the one-year trial. Evidence of liver fat present in the baseline MR images Suitable for liver biopsy using the percutaneous approach Willingness to comply with the follow-up protocol and successful completion of the run-in (described below). Written informed consent.
Exclusion Criteria:
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 1.0 g/dL or more below normal range) or history of coagulopathy. Serum creatinine >1.5 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. Brief psychological evaluation recommendation that individual not continue in the study. 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. Contraindication to MRI scanning. MRI contraindications are assessed during initial eligibility review as well as on the day of scanning using the CMRR standard safety screening form. Individuals that require the trans-jugular approach for liver biopsy History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus. Any history of dysphagia. NAS fibrosis score > 3

Behavioral: Lifestyle Modification Counseling, Procedure: Vertical Sleeve Gastrectomy

Digestive & Liver Health

Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC)

Shannon Jannatpour -
Sayeed Ikramuddin
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