Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study, a sample size of 20 in each group should offer significant information as to the difference in NAS score reduction between to two groups and achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 30 to 70 years at eligibility visit.

• At least one of the following:

• Diagnosed with NASH with a total NAS ≥ 4 including a ballooning score of at least 1

• Diagnosed with T2DM or prediabetes, HbA1c\< 9%

• Body Mass Index (BMI): 35.0-60.0 kg/m2 at eligibility visit.

• Willingness to accept random assignment to either treatment group.

• All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study

• Evidence of liver fat present in the baseline MR images

• Suitable for liver biopsy

• Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).

• Written informed consent.

• English speaking

Locations
United States
California
University of San Fransisco
RECRUITING
San Francisco
Minnesota
University of Minnesota
COMPLETED
Minneapolis
Contact Information
Primary
Shannon Jannatpour, MS
sjannatp@umn.edu
6126727422
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 48
Treatments
Experimental: VSG + LSM
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.
Active_comparator: LSM
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.
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov