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

N/AActive Not RecruitingNCT05507151

West Virginia University30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Nonalcoholic Fatty Liver Disease

Interventions

Endoscopic Sleeve GastroplastyPROCEDURE

endoscopic suturing of the stomach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Before ESG)

Change in Controlled Attenuation Parameter of Steatosis

Time frame: 6 months post ESG

Change in Controlled Attenuation Parameter of Steatosis

Time frame: 12 months post ESG

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.

Time frame: Baseline (Before ESG)

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.

Time frame: 6 months post ESG

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.

Time frame: 12 months post ESG

Secondary Outcomes

Anthropometric Evaluation

Changes in Anthropometric evaluation from baseline to 6 months post ESG

Time frame: 6 months post ESG

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).

Time frame: 6 months post ESG

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).

Time frame: 12 months post ESG

Excess Weight Loss Changes

Percent excess weight loss change from baseline to 6 months

Time frame: 6 months post ESG

Excess Weight Loss Changes

Percentage of excess weight loss change from baseline to 12 months

Time frame: 12 months post ESG

Total Body Weight Loss Changes

Percentage of total body weight loss (TBWL) from baseline to 6 months

Time frame: 6 months post ESG

Total Body Weight Loss Changes

Percentage of total body weight loss (TBWL) from baseline to 12 months

Time frame: 12 months post ESG

Absolute Body Weight Loss Changes

Percentage of Absolute Body Weight Loss from baseline to 6 months

Time frame: 6 months post ESG

Absolute Body Weight Loss Changes

Percentage of Absolute Body Weight Loss from baseline to 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes