NL-OMON54284招募中不适用
Applying Mysimba in patients with weight regain after bariatric surgery - AMPWR
Zuyderland Medisch Centrum0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, a subject must meet all of the
- •following criteria:
- •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
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •Anatomical or surgical abnormalities for which revisional surgery is
- •Use of the following medication Monoamino-oxidase inbibitors (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 who are not able to understand the informed consent form and patient
- •information.
研究者
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