Bariatric Surgery for Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

Overseen by Sayeed Ikramuddin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Minnesota

No Placebo Group

Trial Summary

What is the purpose of this trial?

Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver disease; and (iii) the responses to bariatric surgery. These experiments will support deeper future mechanistic investigations of the metabolic mechanisms underlying nonalcoholic steatohepatitis (NASH) improvement with bariatric surgery. The premise of this study is that deranged hepatic mitochondrial metabolism is a key biomarker and mediator of the nonalcoholic fatty liver disease (NAFLD)/NASH continuum, and the central hypothesis the investigators will test is that preoperative hepatic fat oxidation and glucose production flux parameters differ between low versus high NAFLD activity score (NAS), and response of the liver to bariatric surgery can be predicted by preoperative fluxes.

Research Team

Sayeed Ikramuddin, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

Adults aged 18-67 with a BMI of 30.0-55.0 kg/m2, diagnosed with NASH (NAS ≥3) or non-NASH/NAFLD (NAS ≤3), and possibly T2DM or prediabetes are eligible for this trial focused on liver health in relation to obesity. Participants must consent to surgery, live near the clinic for follow-ups, have insurance covering obesity treatments, and be suitable for liver biopsy.

Inclusion Criteria

Expect to live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial

Your body mass index (BMI) is between 30 and 55.

Diagnosed with NASH with a total NAS ≥ 3 including a ballooning score of at least 1, or non-NASH/NAFLD with a total NAS ≤3, or Diagnosed with T2DM or prediabetes, HbA1c< 8% , or CAP score greater than or equal to 248 on Fibroscan

Exclusion Criteria

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.

I have not taken specific medications that could cause fatty liver disease in the last 2 months.

Treatment Details

Interventions

• Vertical Sleeve Gastrectomy (VSG) (Procedure)

Trial Overview The study is testing how Vertical Sleeve Gastrectomy (VSG), a type of bariatric surgery, affects liver function—specifically fat burning and glucose production—in patients with varying severities of fatty liver disease related to obesity.

Participant Groups

Group I: Vertical Sleeve Gastrectomy (VSG) Experimental Treatment 1 Intervention

Bariatric surgical procedure

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School