Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis (NCT03587831)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of San Fransisco — San Francisco, California
Age range: 30 Years to 70 Years
🧪 Interventions in This Study
- Vertical Sleeve Gastrectomy (PROCEDURE)
- Lifestyle Modification Counseling (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- University of San Fransisco — San Francisco, California
- Pennington Biomedical Research Center — Baton Rouge, Louisiana
- Minneapolis VA Medical Center — Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota
📞 Contact the Study Coordinator
Phone: (612) 672-7422
Email: sjannatp@umn.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in NASH - Nonalcoholic Steatohepatitis
- Statins for the Treatment of NASH — Rochester, Minnesota
- A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) — Birmingham, Alabama
- Estrogen Administration for the Treatment of NASH in Postmenopausal Women — Boston, Massachusetts
- A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis — Birmingham, Alabama
- Novel MRE Technique to Assess a Risk Factor for Liver Cancer — Stanford, California
- Hepatic Energy Fluxes in NASH and NAS Patients — Minneapolis, Minnesota
Explore by condition: All NASH - Nonalcoholic Steatohepatitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.