Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). Our hypothesis is that intra-gastric injection of Botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 to 65yrs old
- •BMI >32.5 (Class II obesity)
排除标准
- •Pregnancy or lactation
- •Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
- •Patients with known liver cirrhosis or known esophageal/gastric varices
- •Known eating disorders
- •Known major cardiovascular or pulmonary conditions
- •Previous gastric/bariatric surgery
- •Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
- •Known alcohol or drug abuse
- •Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product
研究组 & 干预措施
Intervention Arm
Patients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above
Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox.
干预措施: Botulinum toxin type A (Drug)
Intervention Arm
Patients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above
Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox.
干预措施: Weight Management Program (Behavioral)
Control Arm
Patients will undergo a 12-week weight management program.
干预措施: Weight Management Program (Behavioral)
结局指标
主要结局
Weight loss
时间窗: 1 year
Examine the average weight loss
Time to weight regain following a single injection of intra-gastric Botox
时间窗: 1 year
次要结局
- Gut hormone level(1 year)
- Gut hormone level ( Leptin)(1 year)
- Satiety index(1 year)
- Co-morbidities(1 year)
研究者
Danson Yeo Xue Wei
Associate Consultant
Tan Tock Seng Hospital