Prevalence and trends in obesity among US adults, 1999-2008.
Katherine M Flegal, Margaret D Carroll, Cynthia L Ogden...
https://pubmed.ncbi.nlm.nih.gov/20071471Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06138821
Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial
Led by Pichamol Jirapinyo, MD, MPH · Updated on 2025-12-02
132
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
P
Pichamol Jirapinyo, MD, MPH
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease worldwide, often linked to obesity. This research investigates the effect of combining endoscopic sleeve gastroplasty (ESG), a minimally-invasive weight loss procedure, with lifestyle changes compared to lifestyle changes alone for patients with metabolic dysfunction-associated steatohepatitis (MASH). The study aims to better understand how ESG impacts MASH and related liver conditions in adults with obesity. Participants will be randomly assigned to one of two groups: one receiving ESG plus a lifestyle modification program, and the other undergoing lifestyle modification alone. ESG involves using an FDA-approved device to reduce stomach size by about 70%, helping to induce weight loss. Both groups will follow their assigned lifestyle program for 12 months, focusing on diet and exercise. Throughout the study, participants will have regular assessments including liver biopsies at the start and after one year to measure MASH resolution and liver fibrosis. Researchers will also track changes in liver stiffness, fat content, weight loss, quality of life, eating behaviors, insulin resistance, and safety parameters. The total duration for participant involvement is 12 months, with multiple check-ins to monitor progress and collect data.
CONDITIONS
Brief Title
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (male or female)
- Body mass index (BMI) of 30 kg/m2 or higher
- Stable body weight with no change greater than 5% for 6 months before the first study visit
- Willingness to follow all study requirements including informed consent, follow-up visits, tests, and diet counseling
- Willingness to avoid starting new anti-obesity medications for 12 months
- Living within reasonable travel distance to the study center for follow-up
- Ability to provide informed consent
- Women of childbearing potential must agree to use effective birth control methods
You will not qualify if you...
- History of chronic liver diseases other than MASLD/MASH (such as viral or autoimmune hepatitis)
- Use of vitamin E (over 800 IU/day), pioglitazone, obeticholic acid, or resmetirom within 90 days before study start
- Previous foregut or gastrointestinal surgery except simple procedures like fundoplication, cholecystectomy, or appendectomy
- Prior bariatric surgery or prior endoscopic sleeve gastroplasty
- Any inflammatory gastrointestinal diseases or severe esophagitis
- Conditions causing risk of upper gastrointestinal bleeding or anatomical abnormalities that affect endoscope passage
- Severe gastroesophageal reflux disease (GERD) or severe esophageal motility disorders
- Chronic abdominal pain, gastroparesis, or intractable constipation
- Liver failure or cirrhosis
- Severe bleeding disorders
- Insulin-dependent diabetes or high likelihood of needing insulin in next 12 months or hemoglobin A1C 10% or higher
- Use of antiplatelet, anticoagulant, corticosteroids, immunosuppressants, narcotics, anti-seizure, or anti-arrhythmic medications
- Pregnancy or breastfeeding
- Excessive alcohol use or active smoking
- History of uncontrolled heart or respiratory diseases, autoimmune connective tissue disorders, active cancer, genetic or hormonal obesity causes, endocrine disorders affecting weight, eating disorders, or psychological issues preventing lifestyle participation as determined by a psychologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day
Participants assigned to the endoscopic sleeve gastroplasty group undergo a minimally invasive endoscopic procedure to reduce stomach size by 70%, followed by a lifestyle modification program.
1 procedure day visit
Outpatient Treatment
Duration - 12 months
Participants assigned to the lifestyle modification group and those who had ESG participate in a lifestyle modification program involving diet and exercise therapy for weight loss.
Regular visits for counseling and monitoring throughout 12 months
Follow-up
Duration - 12 months
Participants are monitored for safety parameters and outcomes such as weight loss, liver health, and quality of life at multiple time points after the procedure or lifestyle modification.
Visits at 1, 3, 6, 9, and 12 months post-procedure or start of lifestyle modification
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
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Research Team
M
Michele Research Manager, MS
S
Samantha Clinical Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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