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Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976443
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):
Mark Topazian, 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: BTA Drug: Placebo (normal saline) Phase 1

Detailed Description:
Additional information regarding study interventions can be obtained by contacting study staff.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Placebo Comparator: Placebo (normal saline)
Gastric injections of normal saline
Drug: Placebo (normal saline)
Placebo (normal saline), gastric injections of normal saline

Active Comparator: BTA 100 U
Gastric injections of botulinum toxin A, 100 Units
Drug: BTA
BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
Other Name: Botox

Active Comparator: BTA 300 U
BTA 300 U, gastric injections under EUS guidance
Drug: BTA
BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
Other Name: Botox

Primary Outcome Measures :
  1. Change in body weight between baseline and 16 weeks after BTA injection. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change in BMI and waist circumference [ Time Frame: 16 weeks ]
  2. Change in gastric emptying T½ [ Time Frame: Baseline to 2 weeks ]
  3. Change in nutrient drink test maximum tolerated volume (MTV) [ Time Frame: 16 weeks ]
  4. Change in gastrointestinal symptoms over time [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00976443

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Mark Topazian, M.D. Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mark Topazian, Professor of Medicine, Mayo Clinic Identifier: NCT00976443    
Other Study ID Numbers: 09-000002
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: January 2013
Keywords provided by Mark Topazian, Mayo Clinic:
Gastric Emptying
Feeding Behavior
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight