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Completed

NCT Number: NCT00976443

Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTA

Drug

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

Other names: Botox

Placebo (normal saline)

Drug

Placebo (normal saline), gastric injections of normal saline

Primary outcomes

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

    Time frame: 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2009
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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