Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.
There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •BMI > 35
排除标准
- •Known hypersensitivity to medication
- •Neuro muscular disease
- •Dysphagia
- •Tendency for aspiration
- •Use of aminoglycoside antibiotics and/or spectinomycin lately
- •Previous side effects of botox injections
- •Previous bariatric surgery
- •Previous cancer in GI-tract
- •Other obesity treatment last 12 months
- •Severe eating disorder
- •Hypothyroidism
- •Pregnancy/brest feeding
- •Reduced competence to consent
研究组 & 干预措施
Botulinum toxin A
Botulinum toxin type A injection in muscles of stomach wall
干预措施: Botulinum Toxin Type A (Drug)
Saline solution
Placebo (saline solution) injection first 6 months, then active treatment
干预措施: Botulinum Toxin Type A (Drug)
Saline solution
Placebo (saline solution) injection first 6 months, then active treatment
干预措施: Saline solution (Drug)
结局指标
主要结局
Body weight
时间窗: Change from baseline to 6 months; 1 year; 5 years
次要结局
未报告次要终点
