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

Phase 2

• Conditions: Obesity; Weight Loss
• Interventions: Drug: Botulinum toxin type A; Behavioral: Weight Management Program

• Registration Number: NCT04274608
• Lead Sponsor: Tan Tock Seng Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-16
• Study First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Age 21 to 65yrs old
2. BMI >32.5 (Class II obesity)

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Exclusion Criteria

1. Pregnancy or lactation
2. Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
3. Patients with known liver cirrhosis or known esophageal/gastric varices
4. Known eating disorders
5. Known major cardiovascular or pulmonary conditions
6. Previous gastric/bariatric surgery
7. Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
8. Known alcohol or drug abuse
9. Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Botulinum toxin type A	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.
Intervention Arm	Weight Management Program	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.
Control Arm	Weight Management Program	Patients will undergo a 12-week weight management program.

Primary Outcome Measures

Name	Time	Method
Weight loss	1 year	Examine the average weight loss
Time to weight regain following a single injection of intra-gastric Botox	1 year

Secondary Outcome Measures

Name	Time	Method
Gut hormone level	1 year	Ghrelin
Gut hormone level ( Leptin)	1 year	Leptin
Satiety index	1 year
Co-morbidities	1 year	Diabetes, hypertension, hyperlipidemia

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore