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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507151
• Other study ID #: 2202523300
• Status: Recruiting
• Start date: August 24, 2022
• Est. completion date: May 2024

Study information

• Verified date: April 2023
• Source: West Virginia University
• Contact: Shailendra Singh, MD
• Phone: 304-293-4123
• Email: shailendra.singh[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Procedure:
• Endoscopic Sleeve Gastroplasty
endoscopic suturing of the stomach

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Controlled Attenuation Parameter of Steatosis	The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.	Baseline (Before ESG)
Primary	Change in Controlled Attenuation Parameter of Steatosis	The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.	6 months post ESG
Primary	Change in Controlled Attenuation Parameter of Steatosis	The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change.	12 months post ESG
Primary	Change in Liver Stiffness Measurement of Fibrosis	Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.	Baseline (Before ESG)
Primary	Change in Liver Stiffness Measurement of Fibrosis	Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.	6 months post ESG
Primary	Change in Liver Stiffness Measurement of Fibrosis	Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease.	12 months post ESG
Secondary	Anthropometric Evaluation	Changes in Anthropometric evaluation from baseline to 6 months post ESG	6 months post ESG
Secondary	BMI Changes	Compare the change in BMI from baseline to the 6 months post ESG. Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet).	6 months post ESG
Secondary	BMI Changes	Compare the change in BMI from baseline to the 12 months post ESG. Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet).	12 months post ESG
Secondary	Excess Weight Loss Changes	Percent excess weight loss change from baseline to 6 months	6 months post ESG
Secondary	Excess Weight Loss Changes	Percentage of excess weight loss change from baseline to 12 months	12 months post ESG
Secondary	Total Body Weight Loss Changes	Percentage of total body weight loss (TBWL) from baseline to 6 months	6 months post ESG
Secondary	Total Body Weight Loss Changes	Percentage of total body weight loss (TBWL) from baseline to 12 months	12 months post ESG
Secondary	Absolute Body Weight Loss Changes	Percentage of Absolute Body Weight Loss from baseline to 6 months	6 months post ESG
Secondary	Absolute Body Weight Loss Changes	Percentage of Absolute Body Weight Loss from baseline to 12 months	12 months post ESG