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Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976443
First Posted: September 14, 2009
Last Update Posted: January 3, 2013
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.
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic
  Purpose
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 Intervention Phase
Obesity Drug: BTA Drug: Placebo (normal saline) Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Mark Topazian, Mayo Clinic:

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

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

Enrollment: 60
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00976443


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Topazian, M.D. Mayo Clinic
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Topazian, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00976443     History of Changes
Other Study ID Numbers: 09-000002
First Submitted: September 11, 2009
First Posted: September 14, 2009
Last Update Posted: January 3, 2013
Last Verified: January 2013

Keywords provided by Mark Topazian, Mayo Clinic:
Obesity
Gastric Emptying
Satiation
Endosonography
Endoscopy
Feeding Behavior

Additional relevant MeSH terms:
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs