Clinical trial NCT05507151: Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis
Official title: Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nonalcoholic Fatty Liver Disease
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 obese patients undergoing an endoscopic sleeve gastroplasty (ESG).

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in Controlled Attenuation Parameter of Steatosis
timeFrame: Baseline (Before ESG)
measure: Change in Controlled Attenuation Parameter of Steatosis
timeFrame: 6 months post ESG
measure: Change in Controlled Attenuation Parameter of Steatosis
timeFrame: 12 months post ESG
measure: Change in Liver Stiffness Measurement of Fibrosis
timeFrame: Baseline (Before ESG)
measure: Change in Liver Stiffness Measurement of Fibrosis
timeFrame: 6 months post ESG
measure: Change in Liver Stiffness Measurement of Fibrosis
timeFrame: 12 months post ESG
Secondary outcomes:
measure: Anthropometric Evaluation
timeFrame: 6 months post ESG
measure: BMI Changes
timeFrame: 6 months post ESG
measure: BMI Changes
timeFrame: 12 months post ESG
measure: Excess Weight Loss Changes
timeFrame: 6 months post ESG
measure: Excess Weight Loss Changes
timeFrame: 12 months post ESG
measure: Total Body Weight Loss Changes
timeFrame: 6 months post ESG
measure: Total Body Weight Loss Changes
timeFrame: 12 months post ESG
measure: Absolute Body Weight Loss Changes
timeFrame: 6 months post ESG
measure: Absolute Body Weight Loss Changes
timeFrame: 12 months post ESG
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Shailendra Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: