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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
Must not have
Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
Timeline
Screening 3 days
Treatment 12 months
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a heart attack or stroke in the last 6 months.
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I have heart failure, chest pain, or symptoms related to poor blood flow in my limbs.
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My heart test shows surgery or intense medical measures are risky for me.
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I have significant anemia or a history of bleeding disorders.
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I have had surgery on my stomach, bile duct, pancreas, spleen, or colon.
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I have had a stomach or upper small intestine ulcer in the last 6 months.
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I have had an organ transplant.
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I have HIV, active tuberculosis, malaria, hepatitis B or C, or cirrhosis.
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I have depression with a CESD score over 17 and am not considered suitable for surgery by a psychologist.
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My EKG results suggest surgery is risky for me.
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I have had esophagitis or Barrett's esophagus, and I've experienced difficulty swallowing.
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I have not taken specific medications that could cause fatty liver disease in the last 2 months.
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I haven't taken pioglitazone or high-dose vitamin E in the last 2 months.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,423 Previous Clinical Trials
1,619,767 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
~3 spots leftby Nov 2025
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