View Clinical Trial (Medical Research Study)
Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects - NCT00976443-55905(Clinical Trial 330879)
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Rochester |
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State:
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MN |
| Zip Code: |
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55905 |
| Conditions: |
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Obesity - Gastric Emptying |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Mayo Clinic
Rochester, MN 55905
United States
Primary Contact:
Amy Boldingh
Email: boldingh.amy@mayo.edu
Phone: 507-538-6599
Secondary Contact:
Amy Boldingh
Email: boldingh.amy@mayo.edu
Phone: 507-538-6599 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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