Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial

Study Overview
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Brief Summary
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This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). Our hypothesis is that intra-gastric injection of Botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone.

Official Title
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Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial

Conditions
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Obesity, Weight Loss

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Behavioral: Weight Management Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 to 65yrs old BMI >32.5 (Class II obesity) Exclusion Criteria: Pregnancy or lactation Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy) Patients with known liver cirrhosis or known esophageal/gastric varices Known eating disorders Known major cardiovascular or pulmonary conditions Previous gastric/bariatric surgery Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer) Known alcohol or drug abuse Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Patients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox. | Drug: Botulinum toxin type A<br>* Intragastric injection of Botulinum toxin type A<br>Behavioral: Weight Management Program<br>* 12 week weight management program<br>|
| Active Comparator: Control Arm<br>Patients will undergo a 12-week weight management program. | Behavioral: Weight Management Program<br>* 12 week weight management program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Examine the average weight loss | 1 year | 
| Time to weight regain following a single injection of intra-gastric Botox |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut hormone level | Ghrelin | 1 year | 
| Gut hormone level ( Leptin) | Leptin | 1 year | 
| Satiety index |  | 1 year | 
| Co-morbidities | Diabetes, hypertension, hyperlipidemia | 1 year |