Clinical trial NCT00976443: Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects
Official title: Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Gastric Emptying
Satiation
Endosonography
Endoscopy
Feeding Behavior
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Additional information regarding study interventions can be obtained by contacting study staff.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 60 years
* BMI ≥ 35 kg /m²
* No history of diabetes, gastric or small bowel surgery, known gastroparesis, prior peptic ulcer, esophagitis, or gastrointestinal stricture.
* Not pregnant or nursing. Women of childbearing potential must have a negative urine pregnancy test within 48 hours prior to each gastric emptying study, and the Botox injection procedure.

Exclusion Criteria:

* Unable or unwilling to provide written informed consent
* ASA Class III or higher
* Chronic upper abdominal pain, nausea, or vomiting
* Allergy to botulinum toxin
* Delayed gastric emptying (abnormal T ½) on baseline scintigraphic gastric emptying test
* Active esophageal, gastric, or duodenal ulceration at time of diagnostic EGD
* Allergic to both penicillins AND quinolones
* Subject has taken warfarin (Coumadin) or clopidogrel (Plavix) in the week preceding EUS

Primary outcomes:
measure: Change in body weight between baseline and 16 weeks after BTA injection.
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in BMI and waist circumference
timeFrame: 16 weeks
measure: Change in gastric emptying T½
timeFrame: Baseline to 2 weeks
measure: Change in nutrient drink test maximum tolerated volume (MTV)
timeFrame: 16 weeks
measure: Change in gastrointestinal symptoms over time
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Topazian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.