RECRUITING

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

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Conditions

Nonalcoholic Fatty Liver Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease

Quick Facts

Study Start:2022-08-24
Study Completion:2024-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05507151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
  2. * Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
  3. * Patients older than 18 years and younger than 75 years of age at the time of consent
  4. * Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
  5. * Patients willing and able to comply with study requirements for follow-up
  1. * Patients who are treated with intragastric balloons
  2. * Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
  3. * Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
  4. * Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
  5. * Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
  6. * Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy
  7. * 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
  8. * Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer \>1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency,
  9. * Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent.
  10. * The patient refuses or is unable to provide written informed consent
  11. * Prior bariatric treatment procedure

Contacts and Locations

Study Contact

Shailendra Singh, MD
CONTACT
304-293-4123
shailendra.singh@hsc.wvu.edu

Principal Investigator

Shailendra Singh, MD
PRINCIPAL_INVESTIGATOR
West Virginia University

Study Locations (Sites)

West Virginia University
Morgantown, West Virginia, 26508
United States

Collaborators and Investigators

Sponsor: West Virginia University

  • Shailendra Singh, MD, PRINCIPAL_INVESTIGATOR, West Virginia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-24
Study Completion Date2024-05

Study Record Updates

Study Start Date2022-08-24
Study Completion Date2024-05

Terms related to this study

Additional Relevant MeSH Terms

  • Nonalcoholic Fatty Liver Disease