Overview

Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Botulinum Toxins
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