Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in body weight between baseline and 16 weeks after BTA injection.
研究概览
简要总结
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.
详细描述
Additional information regarding study interventions can be obtained by contacting study staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo (normal saline)
Gastric injections of normal saline
干预措施: Placebo (normal saline) (Drug)
BTA 100 U
Gastric injections of botulinum toxin A, 100 Units
干预措施: BTA (Drug)
BTA 300 U
BTA 300 U, gastric injections under EUS guidance
干预措施: BTA (Drug)
结局指标
主要结局
Change in body weight between baseline and 16 weeks after BTA injection.
时间窗: 16 weeks
次要结局
- Change in nutrient drink test maximum tolerated volume (MTV)(16 weeks)
- Change in BMI and waist circumference(16 weeks)
- Change in gastric emptying T½(Baseline to 2 weeks)
- Change in gastrointestinal symptoms over time(24 weeks)