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.
Additional information regarding study interventions can be obtained by contacting study staff.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
Placebo (normal saline), gastric injections of normal saline
Mayo Clinic
Rochester, Minnesota, United States
Change in body weight between baseline and 16 weeks after BTA injection.
Time frame: 16 weeks
Change in BMI and waist circumference
Time frame: 16 weeks
Change in gastric emptying T½
Time frame: Baseline to 2 weeks
Change in nutrient drink test maximum tolerated volume (MTV)
Time frame: 16 weeks
Change in gastrointestinal symptoms over time
Time frame: 24 weeks
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