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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic sleeve gastroplasty/Transoral outlet reduction | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobariatric procedure | Procedure | Endoscopic sleeve gastroplasty or transoral outlet reduction |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liliana Bancila, PhD | Contact | 310-423-3872 | Liliana.Bancila@cshs.org | |
| Joseph Meza | Contact | 310-423-6082 | Joseph.Meza@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Park, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liliana Bancila | Recruiting | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |