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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.
 
ClinicalTrials.gov Identifier: NCT00976443
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Last Update Posted Date January 3, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Change in body weight between baseline and 16 weeks after BTA injection. [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects
Official Title  ICMJE Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections
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.
Detailed Description Additional information regarding study interventions can be obtained by contacting study staff.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: BTA
    BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
    Other Name: Botox
  • Drug: Placebo (normal saline)
    Placebo (normal saline), gastric injections of normal saline
Study Arms  ICMJE
  • Placebo Comparator: Placebo (normal saline)
    Gastric injections of normal saline
    Intervention: Drug: Placebo (normal saline)
  • Active Comparator: BTA 100 U
    Gastric injections of botulinum toxin A, 100 Units
    Intervention: Drug: BTA
  • Active Comparator: BTA 300 U
    BTA 300 U, gastric injections under EUS guidance
    Intervention: Drug: BTA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976443
Other Study ID Numbers  ICMJE 09-000002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Topazian, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Topazian, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP