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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Drug: Botulinum toxin type A; Behavioral: Weight Management Program

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Danson Yeo, MBBS, MRCS, FRCS; Phone Number: +65 81834111; Email: danson_xw_yeo@ttsh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Danson Yeo, MBBS; Phone Number: +65 81834111; Email: danson_xw_yeo@ttsh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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; Intragastric injection of Botulinum toxin type A; Behavioral: Weight Management Program; 12 week weight management program
Active Comparator: Control Arm; Patients will undergo a 12-week weight management program.	Behavioral: Weight Management Program; 12 week weight management program

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: February 16, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: TanTockSengH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No