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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Sleeve Gastroplasty | endoscopic suturing of the stomach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Sleeve Gastroplasty | Procedure | endoscopic suturing of the stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric Evaluation | Changes in Anthropometric evaluation from baseline to 6 months post ESG | 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). |
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Inclusion Criteria:
Exclusion criteria:
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30 obese patients undergoing an endoscopic sleeve gastroplasty (ESG).
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| Name | Affiliation | Role |
|---|---|---|
| Shailendra Singh, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26508 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| 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. | 12 months post ESG |
| 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). | 12 months post ESG |
| Excess Weight Loss Changes | Percent excess weight loss change from baseline to 6 months | 6 months post ESG |
| Excess Weight Loss Changes | Percentage of excess weight loss change from baseline to 12 months | 12 months post ESG |
| Total Body Weight Loss Changes | Percentage of total body weight loss (TBWL) from baseline to 6 months | 6 months post ESG |
| Total Body Weight Loss Changes | Percentage of total body weight loss (TBWL) from baseline to 12 months | 12 months post ESG |
| Absolute Body Weight Loss Changes | Percentage of Absolute Body Weight Loss from baseline to 6 months | 6 months post ESG |
| Absolute Body Weight Loss Changes | Percentage of Absolute Body Weight Loss from baseline to 12 months | 12 months post ESG |