Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

Study Overview
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Brief Summary
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Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.

Detailed Description
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Additional information regarding study interventions can be obtained by contacting study staff.

Official Title
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Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections

Conditions
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Obesity

Intervention / Treatment
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* Drug: BTA
* Drug: Placebo (normal saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and ≤ 60 years BMI ≥ 35 kg /m² No history of diabetes, gastric or small bowel surgery, known gastroparesis, prior peptic ulcer, esophagitis, or gastrointestinal stricture. Not pregnant or nursing. Women of childbearing potential must have a negative urine pregnancy test within 48 hours prior to each gastric emptying study, and the Botox injection procedure. Exclusion Criteria: Unable or unwilling to provide written informed consent ASA Class III or higher Chronic upper abdominal pain, nausea, or vomiting Allergy to botulinum toxin Delayed gastric emptying (abnormal T ½) on baseline scintigraphic gastric emptying test Active esophageal, gastric, or duodenal ulceration at time of diagnostic EGD Allergic to both penicillins AND quinolones Subject has taken warfarin (Coumadin) or clopidogrel (Plavix) in the week preceding EUS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (normal saline)<br>Gastric injections of normal saline | Drug: Placebo (normal saline)<br>* Placebo (normal saline), gastric injections of normal saline<br>|
| Active Comparator: BTA 100 U<br>Gastric injections of botulinum toxin A, 100 Units | Drug: BTA<br>* BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum<br>* Other names: Botox;|
| Active Comparator: BTA 300 U<br>BTA 300 U, gastric injections under EUS guidance | Drug: BTA<br>* BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight between baseline and 16 weeks after BTA injection. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI and waist circumference |  | 16 weeks | 
| Change in gastric emptying T½ |  | Baseline to 2 weeks | 
| Change in nutrient drink test maximum tolerated volume (MTV) |  | 16 weeks | 
| Change in gastrointestinal symptoms over time |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Gastric Emptying, Satiation, Endosonography, Endoscopy, Feeding Behavior