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VSG + Lifestyle Changes for Fatty Liver Disease

N/A
Recruiting
Led By Sayeed Ikramuddin, M.D., M.H.A.
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 30 to 70 years at eligibility visit
Diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1 or Diagnosed with T2DM or prediabetes, HbA1c < 9%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights

Study Summary

This trial is testing whether a lifestyle modification or a Vertical Sleeve Gastrectomy (VSG) is more effective in reducing non-alcoholic steatohepatitis (NASH) score.

Who is the study for?
This trial is for adults aged 30-70 with a BMI of 35.0-50.0 kg/m2, diagnosed with NASH (a type of liver disease) or prediabetes/T2DM, and an HbA1c level below 9%. Participants must consent to random treatment assignment, have insurance covering obesity treatments, live within two hours of the clinic, and be suitable for a liver biopsy.Check my eligibility
What is being tested?
The study compares lifestyle modification alone versus vertical sleeve gastrectomy (VSG) combined with lifestyle changes over 12 months to see which better reduces liver damage in NASH patients. It aims to recruit and retain participants for invasive/non-invasive measurements and assess the safety of VSG.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 stomach size, and general anesthesia risks. Lifestyle modifications typically have minimal side effects but can include muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 30 and 70 years old.
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I have NASH with a specific severity score, or I have type 2 diabetes or prediabetes with controlled HbA1c.
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My insurance covers obesity treatments and any related surgery complications.
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I can safely undergo a liver biopsy.

Timeline

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

Treatment Details

Study Objectives

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VSG + LSMExperimental Treatment2 Interventions
Procedure/Surgery: Vertical Sleeve Gastrectomy will be performed using five laparoscopic ports. The short gastric and epiploic vessels will be taken down With a 40 French Bougie in place, the greater curvature will be excised starting 6 cm proximal to the pylorus. Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention will align with methods listed in the LSM arm description. However, participants assigned to the VSG will not have calorie ceilings during the first 6 months of rapid weight loss, and they will receive additional instruction regarding food volume and adequate protein intake.
Group II: LSMActive Control1 Intervention
Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention is modeled after the LookAHEAD trial, with modules modified for participants undergoing surgery, and designed to produce maximum achievable weight loss. Both groups will increase their level of moderate-intensity physical activity (such as walking) to a total of 325 minutes per week. All lifestyle-medical management participants will be given calorie intake targets of 1200, 1500, or 1800 kilocalories per day, depending on body weight, with the goal of producing a weight loss of 1 to 2 pounds per week. There will be 24 weekly counseling meetings during the first 6 months, bi-weekly meetings between months 7 and 9, and monthly meetings between months 10 and 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vertical Sleeve Gastrectomy
2009
N/A
~140

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,461 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
58 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sayeed Ikramuddin, M.D., M.H.A.Principal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
2021. "Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03587831.
All > Autoimmune Hepatitis > Nash
~1 spots leftby Jun 2024
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