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Clinical Trial Summary

Nearly 50% of the U.S. adult population have obesity. Efforts to reduce the burden have been hindered by the lack of access to effective therapies and poor understanding of obesity phenotypes and how patients would respond to each therapy. Endoscopic sleeve gastroplasty (ESG) is one of the most commonly performed endoscopic bariatric and metabolic therapies (EBMTs) in the U.S. First performed by Thompson and Hawes in 2012, ESG involves the use of a Food and Drug Administration (FDA)-cleared endoscopic suturing or plication device to reduce the volume of the stomach. At 12 months, patients experience an average of 16.5% total weight loss (TWL) with a clinically meaningful reduction in hemoglobin A1c (HbA1c), with the durability of up to at least 5 years. In patients who undergo traditional bariatric surgery, there are changes in bile acids (BAs), which stimulate secretion of gut hormones resulting in alteration of gastric emptying rate. This mechanism is thought to contribute to weight loss and early metabolic improvements following bariatric surgery. Furthermore, some studies showed a reduction in inflammatory cytokine levels including interleukin-6 (IL-6) and tumor necrosis factor (TNF-α) following bariatric surgery, which may explain its effect on long-term metabolic improvements. Our group previously demonstrated that following sleeve gastrectomy (SG), a surgical analogue of ESG, the satiety and incretin hormones glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) increase, while the hunger hormone ghrelin decreases. Despite the known efficacy of ESG on weight loss and metabolic comorbidities, its mechanisms of action remain poorly understood. To date, there has been only a single study that assessed the effect of ESG on hormonal profiles (ghrelin and PYY) and gastric emptying. However, the study was limited by 1) lack of data on the major incretin hormone GLP-1, BAs and inflammatory markers and 2) differences in techniques.


Clinical Trial Description

Nearly 50% of the U.S. adult population have obesity. Efforts to reduce the burden have been hindered by the lack of access to effective therapies and poor understanding of obesity phenotypes and how patients would respond to each therapy. Endoscopic sleeve gastroplasty (ESG) is one of the most commonly performed endoscopic bariatric and metabolic therapies (EBMTs) in the U.S. First performed by Christopher C. Thompson and Robert Hawes in 2012, ESG involves the use of a Food and Drug Administration (FDA)-cleared endoscopic suturing or plication device to reduce the volume of the stomach. At 12 months, patients experience an average of 16.5% total weight loss (TWL) with a clinically meaningful reduction in hemoglobin A1c (HbA1c), with the durability of up to at least 5 years. In patients who undergo traditional bariatric surgery, there are changes in bile acids (BAs), which stimulate secretion of gut hormones resulting in alteration of gastric emptying rate. This mechanism is thought to contribute to weight loss and early metabolic improvements following bariatric surgery. Furthermore, some studies showed a reduction in inflammatory cytokine levels including interleukin-6 (IL-6) and tumor necrosis factor (TNF-α) following bariatric surgery, which may explain its effect on long-term metabolic improvements. Our group previously demonstrated that following sleeve gastrectomy (SG), a surgical analogue of ESG, the satiety and incretin hormones glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) increase, while the hunger hormone ghrelin decreases9. Despite the known efficacy of ESG on weight loss and metabolic comorbidities, its mechanisms of action remain poorly understood. The goal of this proposal is to examine the effect of ESG on gut hormones, inflammatory cytokines, BAs and gastric emptying. In 2017, we reported a new ESG technique, also known as distal Primary Obesity Surgery Endoscopy (POSE), where plications are placed in the gastric body to reduce its width and length, which appears to be associated with greater weight loss compared to the original technique focusing on reducing the fundic size. In addition to assisting with the first-in-human ESG cases in 2012 and its iterations using this new technique in 2017, the PI, along with her colleagues, has continued to refine the procedure details to optimize safety, efficiency, efficacy and generalizability. Currently, the PI is leading an observational study assessing the effect of the new ESG technique on various metabolic outcomes. An interim analysis of 25 patients showed mean of 20% TWL at 12 months with improvement in insulin resistance (IR) and hemoglobin A1c (HbA1c). Our overall hypothesis is that there are changes in gut hormones, inflammatory cytokines, BAs and gastric emptying following ESG in the direction that lead to weight loss and improvement in IR. To date, there has been only a single study that assessed the effect of ESG on hormonal profiles (ghrelin and PYY) and gastric emptying. However, the study was limited by 1) lack of data on the major incretin hormone GLP-1, BAs and inflammatory markers and 2) differences in techniques. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04820036
Study type Interventional
Source Brigham and Women's Hospital
Contact Michele B Ryan, MS
Phone 617-525-8266
Email [email protected].harvard.edu
Status Not yet recruiting
Phase N/A
Start date April 2021
Completion date December 2022

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