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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 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 267-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03587831
The ClinicalTrials.gov registry entry for NCT03587831 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 267-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (82% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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