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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03587831
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : June 7, 2023
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Procedure: Vertical Sleeve Gastrectomy Behavioral: Lifestyle Modification Counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
Actual Study Start Date : May 15, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: VSG + LSM

Procedure/Surgery: Vertical Sleeve Gastrectomy will be performed using five laparoscopic ports. The short gastric and epiploic vessels will be taken down With a 40 French Bougie in place, the greater curvature will be excised starting 6 cm proximal to the pylorus.

Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention will align with methods listed in the LSM arm description. However, participants assigned to the VSG will not have calorie ceilings during the first 6 months of rapid weight loss, and they will receive additional instruction regarding food volume and adequate protein intake.

Procedure: Vertical Sleeve Gastrectomy
Surgical Procedure: Vertical Sleeve Gastrectomy

Behavioral: Lifestyle Modification Counseling
Behavioral Intervention: Lifestyle Modification Counseling

Active Comparator: LSM
Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention is modeled after the LookAHEAD trial, with modules modified for participants undergoing surgery, and designed to produce maximum achievable weight loss. Both groups will increase their level of moderate-intensity physical activity (such as walking) to a total of 325 minutes per week. All lifestyle-medical management participants will be given calorie intake targets of 1200, 1500, or 1800 kilocalories per day, depending on body weight, with the goal of producing a weight loss of 1 to 2 pounds per week. There will be 24 weekly counseling meetings during the first 6 months, bi-weekly meetings between months 7 and 9, and monthly meetings between months 10 and 12.
Behavioral: Lifestyle Modification Counseling
Behavioral Intervention: Lifestyle Modification Counseling

Primary Outcome Measures :
  1. Histologic improvements in NAFLD Activity Score (NAS) [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 30 to 70 years at eligibility visit.
  • At least one of the following: a. Diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1. b. 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
  • 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.

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 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&#39;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.
  • History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus.
  • Any history of dysphagia.
  • Fibrosis score > 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03587831

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Contact: Shannon Jannatpour, MS 6126727422
Contact: Allison Wolf 612-626-2498

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United States, California
University of San Fransisco Recruiting
San Francisco, California, United States, 94143
Contact: Bilal Hameed, MD   
Contact: Andrew Posselt, MD, PhD   
Principal Investigator: Bilal Hameed, MD         
Sub-Investigator: Andrew Posselt         
United States, Minnesota
University of Minnesota Completed
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Sayeed Ikramuddin, M.D., M.H.A. University of Minnesota
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Responsible Party: University of Minnesota Identifier: NCT03587831    
Other Study ID Numbers: SURG-2018-26636
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases