Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis

Running, not enrolling

Conditions studied: Nonalcoholic Fatty Liver Disease

In brief

Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.

Key facts

Study ID

NCT05507151

Run by

West Virginia University

People needed

30

Starts

2022-08-24

Expected to finish

2026-05-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
• Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
• Patients older than 18 years and younger than 75 years of age at the time of consent
• Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
• Patients willing and able to comply with study requirements for follow-up

You may not qualify if…

• Patients who are treated with intragastric balloons
• Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
• Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
• Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
• Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
• Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy
• Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease
• Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer >1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency,
• Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent.
• The patient refuses or is unable to provide written informed consent
• Prior bariatric treatment procedure

Where it is running

• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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