Nonalcoholic Fatty Liver DiseaseNCT05507151
Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis
An observational study of Nonalcoholic Fatty Liver Disease, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- Endoscopic Sleeve Gastroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 30 obese patients undergoing an endoscopic sleeve gastroplasty (ESG).
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26508
About this study
Official title: Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease
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.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Endoscopic Sleeve Gastroplasty
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sleeve GastroplastyProcedure or surgery
endoscopic suturing of the stomach
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Sleeve Gastroplasty | endoscopic suturing of the stomach Receives: Procedure: Endoscopic Sleeve Gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Before ESG)
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.
Measured: 6 months post ESG
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post ESG
Secondary outcomes (9)
Anthropometric Evaluation
Changes in Anthropometric evaluation from baseline to 6 months post ESG
Measured: 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).
Measured: 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).
Measured: 12 months post ESG
Excess Weight Loss Changes
Percent excess weight loss change from baseline to 6 months
Measured: 6 months post ESG
Excess Weight Loss Changes
Percentage of excess weight loss change from baseline to 12 months
Measured: 12 months post ESG
Total Body Weight Loss Changes
Percentage of total body weight loss (TBWL) from baseline to 6 months
Measured: 6 months post ESG
Total Body Weight Loss Changes
Percentage of total body weight loss (TBWL) from baseline to 12 months
Measured: 12 months post ESG
Absolute Body Weight Loss Changes
Percentage of Absolute Body Weight Loss from baseline to 6 months
Measured: 6 months post ESG
Absolute Body Weight Loss Changes
Percentage of Absolute Body Weight Loss from baseline to 12 months
Measured: 12 months post ESG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start24 Aug 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shailendra Singh, West Virginia University
- Investigators
- Shailendra Singh, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507151
- Sponsor's protocol ID
- 2202523300
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05507151
- Acronym / sponsor ID
- 2202523300
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Sleeve Gastroplasty | – | Procedure: Endoscopic Sleeve Gastroplastyendoscopic suturing of the stomach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 30 obese patients undergoing an endoscopic sleeve gastroplasty (ESG).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Sleeve Gastroplastyendoscopic suturing of the stomach | Procedure or surgery | Endoscopic Sleeve Gastroplasty |
Primary outcome
Change in Controlled Attenuation Parameter of Steatosis
Time frame: Baseline (Before ESG)
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.
Change in Controlled Attenuation Parameter of Steatosis
Time frame: 6 months post ESG
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.
Change in Controlled Attenuation Parameter of Steatosis
Time frame: 12 months post ESG
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.
Change in Liver Stiffness Measurement of Fibrosis
Time frame: Baseline (Before ESG)
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.
Change in Liver Stiffness Measurement of Fibrosis
Time frame: 6 months post ESG
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.
Change in Liver Stiffness Measurement of Fibrosis
Time frame: 12 months post ESG
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.
9 secondary outcomes
Anthropometric Evaluation
Time frame: 6 months post ESG
BMI Changes
Time frame: 6 months post ESG
BMI Changes
Time frame: 12 months post ESG
Excess Weight Loss Changes
Time frame: 6 months post ESG
Excess Weight Loss Changes
Time frame: 12 months post ESG
Total Body Weight Loss Changes
Time frame: 6 months post ESG
Total Body Weight Loss Changes
Time frame: 12 months post ESG
Absolute Body Weight Loss Changes
Time frame: 6 months post ESG
Absolute Body Weight Loss Changes
Time frame: 12 months post ESG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Related trials for Nonalcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shailendra Singh, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Controlled Attenuation Parameter of Steatosis (time frame: Baseline (Before ESG)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.