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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tan Tock Seng Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

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