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NCT03587831 · ClinicalTrials.gov registry record · NA
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
A NA study of NASH - Nonalcoholic Steatohepatitis, sponsored by University of Minnesota.
- Recruiting
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT03587831: Recruiting NA study of NASH - Nonalcoholic Steatohepatitis, sponsored by University of Minnesota.
NCT03587831 is a NA study of NASH - Nonalcoholic Steatohepatitis that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 48 participants, below the 260-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03587831, a NA study of NASH - Nonalcoholic Steatohepatitis, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- PROCEDURE Vertical Sleeve Gastrectomy
- BEHAVIORAL Lifestyle Modification Counseling
Study Locations (2)
California
- University of San Fransisco - San Francisco
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What NCT03587831 shows while recruiting
NCT03587831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 260-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (82% lower).
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Vertical Sleeve Gastrectomy is the first listed.
NCT03587831 reports a single indexed study location in California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03587831 about?
NCT03587831 is a clinical study titled "Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis". 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...
What is the current status of trial NCT03587831?
This trial is currently recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2021-07-01. Estimated completion is 2026-05-31.
What conditions does trial NCT03587831 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT03587831?
The interventions under investigation include: Vertical Sleeve Gastrectomy (PROCEDURE), Lifestyle Modification Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT03587831?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03587831 being conducted?
This trial has 2 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03587831's enrollment target sits among peer trials
48 21st of 28 higher than 8 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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