Obesity
Conditions
Keywords
Obesity, Gastric Emptying, Satiation, Endosonography, Endoscopy, Feeding Behavior
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.
Detailed description
Additional information regarding study interventions can be obtained by contacting study staff.
Interventions
DRUGBTA
BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
DRUGPlacebo (normal saline)
Placebo (normal saline), gastric injections of normal saline
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight between baseline and 16 weeks after BTA injection. | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed