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Procedure

Bariatric Surgery for Fatty Liver Disease

N/A
Recruiting
Led By Sayeed Ikramuddin
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 67 years at eligible visit
Suitable for liver biopsy using the percutaneous approach
Timeline
Screening 3 days
Treatment 12 months
Follow Up 12 months
Awards & highlights

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.

Who is the study for?
Adults aged 18-67 with a BMI of 30.0-55.0 kg/m2, diagnosed with NASH (NAS ≥3) or non-NASH/NAFLD (NAS ≤3), and possibly T2DM or prediabetes are eligible for this trial focused on liver health in relation to obesity. Participants must consent to surgery, live near the clinic for follow-ups, have insurance covering obesity treatments, and be suitable for liver biopsy.Check my eligibility
What is being tested?
The study is testing how Vertical Sleeve Gastrectomy (VSG), a type of bariatric surgery, affects liver function—specifically fat burning and glucose production—in patients with varying severities of fatty liver disease related to obesity.See study design
What are the potential side effects?
Potential side effects from VSG may include surgical risks like infection or bleeding, nutritional deficiencies due to reduced food intake capacity post-surgery, gastrointestinal issues such as nausea or vomiting, and changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 67 years old.
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I can have a liver biopsy through the skin.
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I am between 18 and 67 years old.
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My insurance covers obesity treatments and surgery complications.
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I can have a liver biopsy through the skin.

Timeline

Screening ~ 3 days
Treatment ~ 12 months
Follow Up ~12 months
This trial's timeline: 3 days for screening, 12 months for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hepatic Energy Fluxes
Secondary outcome measures
Histologic improvements in NAFLD Activity Score (NAS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vertical Sleeve Gastrectomy (VSG)Experimental Treatment1 Intervention
Bariatric surgical procedure

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,387 Previous Clinical Trials
1,552,427 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
88 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sayeed IkramuddinPrincipal InvestigatorUniversity of Minnesota

Media Library

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Vertical Sleeve Gastrectomy (VSG) Highlights & Side Effects. Trial Name: NCT03997422 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to join this research endeavor?

"This clinical trial is seeking 18 potential participants in the 40-67 age range who are displaying signs of weight loss. To be eligible, individuals must meet a myriad of criteria including: having an HbA1c level below 8%, acceptance to undergo surgical intervention after being informed about it, living or working within three hours of the study clinic for one year, and possessing insurance with no exclusion clauses concerning obesity treatments or surgeries. Additionally, vulnerable populations may be allowed to enroll as long they satisfy all inclusion requirements and none of the exclusions."

Answered by AI

Are there still opportunities available for participants to join this experiment?

"According to the official clinicaltrials.gov page, this trial is still enrolling participants. It was first announced on July 1st 2019 and its records were last updated on September 12th 2022."

Answered by AI

Does this medical study accept participants whose age is under eighty years old?

"This clinical trial is inviting participants between the ages of 40 and 67 to join."

Answered by AI

How many participants are currently enrolled in this clinical research?

"Affirmative. Clinicaltrials.gov records display that this clinical study, which initially debuted on July 1st 2019 is currently recruiting patients. 18 participants must be found from a single medical site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Georgia
Other
Minnesota
How old are they?
18 - 65
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

Hoping this will help me , I’ve tired other weight forms . Not been successful.
PatientReceived 2+ prior treatments
I have been struggling w/my weight for years. I'm taking several meds. My current weight is 240 lbs. I am 5'6.
PatientReceived no prior treatments
I've both of these serious health issues in addition to a few others. Chronic control isn't good enough anymore.
PatientReceived 1 prior treatment
I have tried several times unsuccessfully.I hope the structure and support of the study will provide a better solution.
PatientReceived 2+ prior treatments
I have PBC and I have been on Ursodiol 250mg 3 tabs am 3 tabs PM for almost 3 years and my numbers are not going down and I am not sure what my bmi is but I am 335lb and that's down from 360lb and I am 5'3. I have 2 eating disorders BED and I am never hungry and I don't eat .
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Do I need to have surgery to get this vertical sleeve?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Minnesota: < 24 hours
Average response time
  • < 2 Days
~0 spots leftby Jul 2024