Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
Recruiting · 4 sites across 3 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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 this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •People age 30 to 70 at the eligibility visit.
- •You have non-alcoholic steatohepatitis (NASH) with a NAS score of 4 or higher, including a ballooning score of at least 1, OR you have type 2 diabetes (T2DM) or prediabetes with HbA1c less than 9%.
- •Your BMI is between 35.0 and 60.0 at the eligibility visit.
- •You are willing to be randomly assigned to either the lifestyle-only group or the surgery plus lifestyle group.
- •You can have baseline MRI showing liver fat and you are suitable for a liver biopsy; you speak English and can follow the study follow-up plan (including a run-in).
🚫 You may not be able to join if…
- •You had a heart-related event (like heart attack, stroke, or certain heart procedures) in the past 6 months.
- •You currently have congestive heart failure, angina, or symptomatic peripheral vascular disease.
- •You had a pulmonary embolus or thrombophlebitis in the past 6 months.
- •You have had cancer (except basal cell skin cancer or cancer in situ) unless it has been 5 years since you were disease-free.
- •You are pregnant or nursing, or planning to become pregnant within the next 2 years.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults age 30–70
- ✓BMI about 35–60
- ✓You have non-alcoholic steatohepatitis (NASH) and evidence of liver fat on MRI, and can get a liver biopsy
- ✓You have either NASH with specific scoring or prediabetes/type 2 diabetes with HbA1c below 9%
- ✓Not had certain recent heart/lung blood clot events and meet key lab/safety requirements
- !Some conditions may not be a fit: Heart / cardiovascular disease
- !Not for people who are pregnant or breastfeeding
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •There are 2 groups in this study.
What to expect, step by step
· This study lasts about 52 weeks (~12 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 52 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Procedure: Vertical Sleeve Gastrectomy
- Behavioral: Lifestyle Modification Counseling
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
Who's running this study?
Sponsor
University of Minnesota
Overseen by Sayeed Ikramuddin, M.D., M.H.A.
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT03587831 · Locations: California · Louisiana · Minnesota