NCT03206905

Safety, Tolerability, and Sustained Weight Loss of Endoscopic Sleeve Gastroplasty With Diet Modification and Exercise

Safety, Tolerability and Sustained Weight Loss of Immediate Endoscopic Sleeve Gastroplasty (ESG) With Diet Modification and Exercise vs. Early Diet Modification and Exercise and Delayed ESG for the Treatment of Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effect of endoscopic sleeve gastroplasty (ESG) with diet and exercise, to diet and exercise alone, to see which is better in weight loss reduction. Investigators will also compare the effects of ESG to diet and exercise comorbidities such as diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.

Detailed description

This is a single center, prospective randomized case control study with an additional non randomized case arm. This study includes two research interventional groups. Groups A: ESG with diet and exercise modules. Group B: Diet and exercise modules only. Investigators propose to compare ESG to behavioral modification including diet and exercise for patients who have a BMI greater than or equal to 40 kg/m2 or greater than or equal to 30 kg/m2 with 1 or more obesity related co-morbidity and who cannot undergo conventional bariatric surgery(or decline the surgical option). Investigators will also compare the effects of ESG to diet and exercise on comorbidities such as diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Sleeve Gastroplasty	endoscopic, rather than surgical approach, to perform sleeve gastroplasty
BEHAVIORAL	Diet and Exercise	nutritional/exercise counseling

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-07-02
• Last updated: 2022-04-15

Locations

1 site across 1 country: United States