Benefits of Endoscopic Bariatric Procedures

Study Overview
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Brief Summary
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This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe]) as clinically indicated, and subsequent follow up clinic visits for up to one year.

Detailed Description
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The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures. The primary research procedures are: EBT procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe]) Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification Collection of blood to evaluate changes in hormonal profiles

Official Title
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Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Endobariatric procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are considering undergoing EBT for weight loss Patients with a BMI >30 kg/m2 (without obesity related comorbidities) Patients with a BMI >27 kg/m2 (with obesity related comorbidities) Patients willing and able to comply with study requirements for follow-up Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight Individuals 18 years old or older are included Exclusion Criteria: Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD) Esophageal, gastric or duodenal malignancy Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator Pregnant or planning to become pregnant during period of study participation Patient refuses or is unable to provide written informed consent Prior surgical or endoscopic anti-reflux procedure Patients who are unwilling or unable to comply with the follow-up study schedule

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endoscopic sleeve gastroplasty/Transoral outlet reduction<br> | Procedure: Endobariatric procedure<br>* Endoscopic sleeve gastroplasty or transoral outlet reduction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight after various endoscopic bariatric therapies | The investigators will compare mean percentage total body weight loss to baseline, at 1 month, 3 months, 6 months and 1 year post procedure. | Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hormonal profiles after various endoscopic bariatric therapies | Repeated blood draws will be performed, and the following hormones will be measured: ghrelin, glucagon-like peptide 1 (GLP-1), peptide YY (PYY), gastric inhibitory polypeptide (GIP), and oxyntomodulin. We will compare changes over time in hormonal levels after EBT to baseline, 3 months, and 6 months post-procedure. | Baseline/pre-procedure, 3 months, 6 months |