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Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00976443
First received: September 11, 2009
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in body weight between baseline and 16 weeks after BTA injection. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in BMI and waist circumference [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in gastric emptying T½ [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
  • Change in nutrient drink test maximum tolerated volume (MTV) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in gastrointestinal symptoms over time [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: September 11, 2009
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013