Study Summary
This trial is looking at whether bariatric surgery can help improve nonalcoholic fatty liver disease (NAFLD) by measuring the liver's ability to burn fat and make glucose.
Eligible Conditions
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Weight Loss
- Neonatal Abstinence Syndrome
- Bariatric Surgery Candidates
- Overweight or Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 12 months
12 months
Hepatic Energy Fluxes
Histologic improvements in NAFLD Activity Score (NAS)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Vertical Sleeve Gastrectomy (VSG)
1 of 1
Experimental Treatment
18 Total Participants · 1 Treatment Group
Primary Treatment: Vertical Sleeve Gastrectomy (VSG) · No Placebo Group · N/A
Vertical Sleeve Gastrectomy (VSG)
Procedure
Experimental Group · 1 Intervention: Vertical Sleeve Gastrectomy (VSG) · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,260 Previous Clinical Trials
1,485,123 Total Patients Enrolled
Sayeed IkramuddinPrincipal InvestigatorUniversity of Minnesota
Eligibility Criteria
Age 40 - 67 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be between the ages of 18 and 67 years at eligible visit.
You are 30.0-55.0 kg/m2 or have a BMI of 30.0-55.
You must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
You are willing to comply with the follow-up protocol and successfully complete the run-in.
Vulnerable populations will not be targeted for inclusion, but those noted in section 9.1 may be allowed to participate provided they met all of the inclusion and none of the exclusion criteria.\n
Who else is applying?
What state do they live in?
| Texas | 25.0% |
| Georgia | 25.0% |
| Minnesota | 25.0% |
| Other | 25.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Minnesota | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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