Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo (normal saline); Drug: BTA

• Registration Number: NCT00976443
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (normal saline)	Placebo (normal saline)	Gastric injections of normal saline
BTA 100 U	BTA	Gastric injections of botulinum toxin A, 100 Units
BTA 300 U	BTA	BTA 300 U, gastric injections under EUS guidance

Primary Outcome Measures

Name	Time	Method
Change in body weight between baseline and 16 weeks after BTA injection.	16 weeks

Secondary Outcome Measures

Name	Time	Method
Change in BMI and waist circumference	16 weeks
Change in gastric emptying T½	Baseline to 2 weeks
Change in nutrient drink test maximum tolerated volume (MTV)	16 weeks
Change in gastrointestinal symptoms over time	24 weeks

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States