Applying Mysimba in patients with weight regain after bariatric surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss (>5% weight loss) after 22 weeks compared with the regular BOT module alone, in patients with weight regain after bariatric surgery. Assessment of bodyweight is standard part of treatment.
研究概览
简要总结
Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgery
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥18 and <75 years old
- •BMI before surgery was ≥ 35.0 kg/m2
- •Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
- •Gaining more than 5% weight after reaching plateau phase of lowest weight To be eligible to participate in the control patient cohort for measuring bupropion and hydroxybupropion serum levels a subject must meet all of the following criteria: • Patient is ≥18 and <75 years old • Patient is obese (BMI > 30 kg/m2) • Patient on successful Mysimba steady maintenance dose
排除标准
- •Anatomical or surgical abnormalities for which revisional surgery is indicated.
- •Use of the following medication Monoamino-oxidase inhibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
- •Pregnancy or breastfeeding
- •Patients suffering from: o unregulated hypertension o a tumour in the central nervous system o severe liver failure o end stage kidney failure
- •Patients suffering from or with a history of insults
- •Patients with a history of: o bipolar disease o bulimia or anorexia nervosa
- •Patients withdrawing from alcohol or benzodiazepines
- •Patients with excessive use of alcohol or drugs
- •Patients who are not able to understand the informed consent form and patient information.
结局指标
主要结局
The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss (>5% weight loss) after 22 weeks compared with the regular BOT module alone, in patients with weight regain after bariatric surgery. Assessment of bodyweight is standard part of treatment.
The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss (>5% weight loss) after 22 weeks compared with the regular BOT module alone, in patients with weight regain after bariatric surgery. Assessment of bodyweight is standard part of treatment.
次要结局
未报告次要终点
研究者
Stichting Zuyderland Medisch Centrum
Scientific
Zuyderland Medisch Centrum Stichting