- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00976443
Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects
January 2, 2013 updated by: Mark Topazian, Mayo Clinic
Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Additional information regarding study interventions can be obtained by contacting study staff.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo (normal saline)
Gastric injections of normal saline
|
Placebo (normal saline), gastric injections of normal saline
|
Active Comparator: BTA 100 U
Gastric injections of botulinum toxin A, 100 Units
|
BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
Other Names:
|
Active Comparator: BTA 300 U
BTA 300 U, gastric injections under EUS guidance
|
BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body weight between baseline and 16 weeks after BTA injection.
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in BMI and waist circumference
Time Frame: 16 weeks
|
16 weeks
|
Change in gastric emptying T½
Time Frame: Baseline to 2 weeks
|
Baseline to 2 weeks
|
Change in nutrient drink test maximum tolerated volume (MTV)
Time Frame: 16 weeks
|
16 weeks
|
Change in gastrointestinal symptoms over time
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Topazian M, Camilleri M, De La Mora-Levy J, Enders FB, Foxx-Orenstein AE, Levy MJ, Nehra V, Talley NJ. Endoscopic ultrasound-guided gastric botulinum toxin injections in obese subjects: a pilot study. Obes Surg. 2008 Apr;18(4):401-7. doi: 10.1007/s11695-008-9442-x. Epub 2008 Feb 20.
- Topazian M, Camilleri M, Enders FT, Clain JE, Gleeson FC, Levy MJ, Rajan E, Nehra V, Dierkhising RA, Collazo-Clavell ML, Talley NJ, Clark MM. Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight. Clin Gastroenterol Hepatol. 2013 Feb;11(2):145-50.e1. doi: 10.1016/j.cgh.2012.09.029. Epub 2012 Oct 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
September 11, 2009
First Submitted That Met QC Criteria
September 11, 2009
First Posted (Estimate)
September 14, 2009
Study Record Updates
Last Update Posted (Estimate)
January 3, 2013
Last Update Submitted That Met QC Criteria
January 2, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-000002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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