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

2017-07-05 06:53:30 | BioPortfolio

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. We 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.

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. We 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). We 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.

Study Design

Conditions

Obesity

Intervention

Endoscopic Sleeve Gastroplasty, Diet and Exercise

Location

Weill Cornell Medicine, Division of Gastroenterology & Hepatology
New York
New York
United States
10065

Status

Recruiting

Source

Weill Medical College of Cornell University

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-07-05T06:53:30-0400

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Medical and Biotech [MESH] Definitions

Surgical procedures involving the STOMACH and sometimes the lower ESOPHAGUS to correct anatomical defects, or to treat MORBID OBESITY by reducing the size of the stomach. There are several subtypes of bariatric gastroplasty, such as vertical banded gastroplasty, silicone ring vertical gastroplasty, and horizontal banded gastroplasty.

Activities related to WEIGHT REDUCTION in patients with OBESITY. Treatment methods include DIET; EXERCISE; BEHAVIOR MODIFICATION; medications; and BARIATRIC SURGERY.

The exercise capacity of an individual as measured by endurance (maximal exercise duration and/or maximal attained work load) during an EXERCISE TEST.

Controlled physical activity, more strenuous than at rest, which is performed in order to allow assessment of physiological functions, particularly cardiovascular and pulmonary, but also aerobic capacity. Maximal (most intense) exercise is usually required but submaximal exercise is also used. The intensity of exercise is often graded, using criteria such as rate of work done, oxygen consumption, and heart rate.

A diet that contains limited amounts of CARBOHYDRATES. This is in distinction to a regular DIET.

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