Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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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Detailed Description

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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo (normal saline)

Gastric injections of normal saline

Group Type PLACEBO_COMPARATOR

Placebo (normal saline)

Intervention Type DRUG

Placebo (normal saline), gastric injections of normal saline

BTA 100 U

Gastric injections of botulinum toxin A, 100 Units

Group Type ACTIVE_COMPARATOR

BTA

Intervention Type DRUG

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

BTA 300 U

BTA 300 U, gastric injections under EUS guidance

Group Type ACTIVE_COMPARATOR

BTA

Intervention Type DRUG

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

Interventions

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BTA

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

Intervention Type DRUG

Placebo (normal saline)

Placebo (normal saline), gastric injections of normal saline

Intervention Type DRUG

Other Intervention Names

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Botox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes