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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
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Weill Cornell Medicine, Division of Gastroenterology & Hepatology
New York, New York, United States
Start Date
July 1, 2017
Primary Completion Date
December 31, 2018
Completion Date
December 31, 2018
Last Updated
April 15, 2022
2
ACTUAL participants
Endoscopic Sleeve Gastroplasty
PROCEDURE
Diet and Exercise
BEHAVIORAL
Lead Sponsor
Weill Medical College of Cornell University
NCT07472881
NCT01143454
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