Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: BTA; Drug: Placebo (normal saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT00976443

09-000002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 3 patient groups, including a placebo group

Placebo (normal saline)

Placebo Comparator group

Description:

Gastric injections of normal saline

Treatment:

Drug: Placebo (normal saline)

BTA 100 U

Active Comparator group

Description:

Gastric injections of botulinum toxin A, 100 Units

Treatment:

Drug: BTA

BTA 300 U

Active Comparator group

Description:

BTA 300 U, gastric injections under EUS guidance

Treatment:

Drug: BTA