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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Endoscopic Sleeve Gastroplasty
* Behavioral: Diet and Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI greater than or equal to 40 kg/m2, greater than or equal to to 30 kg/m2 with 1 more obesity related co-morbidity, or or greater than or equal to 35 kg/m2 without co-morbidity Co-morbidities include: Sleep apnea (STOP-BANG questionnaire and polysomnography) BP >130/80 or on hypertension meds. A1c > or = to 5.7, fasting >100 OR RANDOM >126, exclude 6.5 and above Waist circumference >102, or 40 inches if male or >80 cm 35 inches if female Metabolic syndrome (3 criteria, blood pressure, waist circumference, triglycerides > 150 or HDL < 50/40) Failure to respond to non-invasive weight loss management for at least 6 months. Valid health insurance to cover the cost of procedure and standard of care pre-and post-procedure management/workup. Exclusion Criteria: Untreated endocrine diseases (diabetes, thyroid disorder, pituitary disorder, and sex gland disorder). diabetes or A1c >6.5 Heart Disease, for example, arrhythmia, heart failure, myocardial infarction. Kidney disease with serum creatinine greater than 2.5 mg/dl. Cerebrovascular disease, for example, stroke or otherwise unable to exercise. Any pregnant or lactating women or who have had childbirth within 6 months. Any patients on retinoid therapy or undergoing retinoid therapy that will not last throughout the length of the trial. Patients with significant psychiatric disorder. Any other chronic condition deemed unsuitable to undergo either arm of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Sleeve Gastroplasty<br> | Procedure: Endoscopic Sleeve Gastroplasty<br>* endoscopic, rather than surgical approach, to perform sleeve gastroplasty<br>Behavioral: Diet and Exercise<br>* nutritional/exercise counseling<br>|
| Active Comparator: Diet and exercise only.<br> | Behavioral: Diet and Exercise<br>* nutritional/exercise counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percentage of Total Body Weight Loss | To compare mean percentage weight loss achieved via ESG with diet modification and exercise, vs. diet modification and exercise only in patients who cannot undergo conventional bariatric surgery for obesity (with 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). | 6 months |