Weight loss surgery and lifestyle changes for treating liver disease

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

This study is testing if weight loss surgery combined with lifestyle changes can help people with liver disease feel better compared to just making lifestyle changes alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 30 Years to 70 Years
• Sex: All
• Sponsor: University of Minnesota (Academic / other)
• Locations: 4 sites (San Francisco, California and 3 other locations)
• Trial ID: NCT03587831 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Vertical Sleeve Gastrectomy (VSG) combined with lifestyle modification compared to lifestyle modification alone in patients with Non-Alcoholic Steatohepatitis (NASH). Participants will be randomized into two groups and followed for 12 months to assess changes in liver histology and other health markers. The study aims to determine the feasibility of recruiting and retaining participants while evaluating the safety and efficacy of VSG in this population. A total of 40 participants will be involved, with assessments including liver biopsies and MRI evaluations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 70 with a BMI of 35-50 kg/m2, diagnosed with NASH or type 2 diabetes, and willing to undergo randomization and liver biopsy.

Not a fit: Patients with recent cardiovascular events or those with contraindications for VSG will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from NASH, potentially leading to improved liver health and weight management.

How similar studies have performed: Previous studies have shown promising results for bariatric surgery in improving liver conditions, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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 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'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).

Where this trial is running

San Francisco, California and 3 other locations

• University of San Fransisco — San Francisco, California, United States (Recruiting)
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Not_yet_recruiting)
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States (Not_yet_recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Completed)

Study contacts

• Principal investigator: Sayeed Ikramuddin, M.D., M.H.A. — University of Minnesota
• Study coordinator: Shannon Jannatpour, MS

Conditions NASH - Nonalcoholic Steatohepatitis