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

  • STATUS
    Recruiting
  • participants needed
    18
  • sponsor
    Tan Tock Seng Hospital
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Updated on 16 February 2024
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botulinum toxin
botox
botulinum toxin type a
weight control
injection of botulinum toxin

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.

Details
Condition Weight Loss, Weight Loss, Obesity, Obesity
Age 21years - 65years
Treatment Botulinum toxin type A, Weight Management Program
Clinical Study IdentifierNCT04274608
SponsorTan Tock Seng Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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