Evaluating endoscopic sleeve gastroplasty for treating fatty liver disease
Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease
West Virginia University · NCT05507151
This study is testing if a procedure called endoscopic sleeve gastroplasty can help people who are very overweight and have fatty liver disease improve their health and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | West Virginia University (other) |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT05507151 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of endoscopic sleeve gastroplasty (ESG) in patients with nonalcoholic fatty liver disease (NAFLD) who are also morbidly obese. The study aims to assess the safety, quality of life, and various metabolic and biochemical changes following the ESG procedure. By focusing on a population that has not been extensively studied in this context, the researchers hope to fill a critical knowledge gap regarding weight management and its effects on liver health. Participants will be monitored for improvements in their health outcomes post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a BMI greater than 30 who are scheduled for ESG.
Not a fit: Patients with certain gastric conditions or those currently using intragastric balloons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-surgical option for weight loss that improves liver health in patients with NAFLD.
How similar studies have performed: While ESG has been studied for obesity management, its application specifically for NAFLD is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion criteria: * 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 this trial is running
Morgantown, West Virginia
- West Virginia University — Morgantown, West Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Shailendra Singh, MD — West Virginia University
- Study coordinator: Shailendra Singh, MD
- Email: shailendra.singh@hsc.wvu.edu
- Phone: 304-293-4123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nonalcoholic Fatty Liver Disease