Status:
COMPLETED
Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects
Lead Sponsor:
Mayo Clinic
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 ul...
Detailed Description
Additional information regarding study interventions can be obtained by contacting study staff.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00976443
Start Date
September 1 2009
End Date
September 1 2011
Last Update
January 3 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905