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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%

Must not have

Previous organ transplantation

Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant.

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I have HIV, active tuberculosis, malaria, hepatitis B or C, cirrhosis, or inflammatory bowel disease.

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I have had surgery on my stomach, bile duct, pancreas, spleen, or colon.

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I have a history of difficulty swallowing.

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I have heart failure, chest pain, or symptoms related to poor blood flow in my limbs.

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I have been cancer-free for 5 years, except for basal cell skin cancer or in situ cancer.

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I have not had a heart attack or stroke in the last six months.

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I have severe anemia or a history of bleeding disorders.

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I have not had a blood clot in my lungs or veins in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary 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

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

0 / 13Eligibility criteria met