Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

Summary

Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.

Timeline

Start

2009-09

Primary completion

2011-09

Completion

2011-09

Publications

• Background Topazian M, Camilleri M, De La Mora-Levy J, Enders FB, Foxx-Orenstein AE, Levy MJ, Nehra V, Talley NJ. Endoscopic ultrasound-guided gastric botulinum toxin injections in obese subjects: a pilot study. Obes Surg. 2008 Apr;18(4):401-7. doi: 10.1007/s11695-008-9442-x. Epub 2008 Feb 20.
• Topazian M, Camilleri M, Enders FT, Clain JE, Gleeson FC, Levy MJ, Rajan E, Nehra V, Dierkhising RA, Collazo-Clavell ML, Talley NJ, Clark MM. Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight. Clin Gastroenterol Hepatol. 2013 Feb;11(2):145-50.e1. doi: 10.1016/j.cgh.2012.09.029. Epub 2012 Oct 9.

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Indications