Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

NCT00976443 | Completed Phase 1 DMC

• 1 other identifier: 09-000002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Gastric Emptying; Satiation; Endosonography; Endoscopy; Feeding Behavior

Outcome Measures

Primary Outcomes (1)

• Change in body weight between baseline and 16 weeks after BTA injection.

  16 weeks

Secondary Outcomes (4)

• Change in BMI and waist circumference

  16 weeks

• Change in gastric emptying T½

  Baseline to 2 weeks

• Change in nutrient drink test maximum tolerated volume (MTV)

  16 weeks

• Change in gastrointestinal symptoms over time

  24 weeks

Study Arms (3)

Placebo (normal saline)

PLACEBO COMPARATOR

Gastric injections of normal saline

Drug: Placebo (normal saline)

BTA 100 U

ACTIVE COMPARATOR

Gastric injections of botulinum toxin A, 100 Units

Drug: BTA

BTA 300 U

ACTIVE COMPARATOR

BTA 300 U, gastric injections under EUS guidance

Drug: BTA

Interventions

BTA DRUG

BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum

Also known as: Botox

BTA 100 U; BTA 300 U

Placebo (normal saline) DRUG

Placebo (normal saline), gastric injections of normal saline

Placebo (normal saline)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 18286347 BACKGROUND

• 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.

  PMID: 23063681 DERIVED

MeSH Terms

Conditions

Obesity; Feeding Behavior

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mark Topazian, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 3, 2013

Record last verified: 2013-01

Locations

US (1)