NL-OMON55792已完成不适用
Influence of body weight on brain structure and function, the BARICO study, BAriatric surgery Rijnstate and RadboudUMC neuroImaging and Cognition in Obesity - The BARICO study
Rijnstate Ziekenhuis0 个研究点目标入组 150 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
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Patients aged 35-55 years
- •- BMI > 40 kg/m2
- •- BMI > 35 and < 40 kg/m2 with co-morbidity, which is expected to improve after
- •surgically-induced weight loss
- •- A history of longstanding obesity (> 5 years)
- •- Proven failed attempts to lose weight in a conventional way, or primarily
- •successful weight loss with eventual weight regain
- •- Intention to adhere to a postoperative follow-up programme.
- •The only additional inclusion criterion for the MRI subgroup (75 patients) of
- •this study includes:
- •- Patients must be willing to undergo MRI scanning and perform tasks in the MRI
- •scanner, at the Donders Institute on three occasions. We include only right
- •handed patients.
排除标准
- •- Previous or current neurological or severe psychiatric illness
- •- Pregnancy
- •- Past or current history of alcohol or drug abuse defined by criteria of the
- •Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
- •- Subjects who received any antibiotic, probiotic, or prebiotic agent three
- •months before and during the start of the study.
- •Contra-indications to operative procedures as regular in bariatric surgery
- •(according to Fried, Interdisciplinary guidelines)
- •- Psychiatric illness or mental instability, psychotic disorders, severe
- •depression and personality disorders
- •- Absence of periods of identifiable medical management
- •- A patient who is unable to participate in prolonged medical follow-up
- •- Alcohol abuse and/or drug dependencies
- •- Diseases threatening life in the short-term or preoperatively
- •- Patients unable to care for themselves, and without long-term family or
- •social support that will warrant such care
- •Contra-indications to MRI scanning:
- •- Claustrophobia
- •- Epilepsy
- •- Pacemakers and defibrillators
- •- Nerve stimulators
- •- Intracranial clips
- •- Intraorbital or intraocular metallic fragments
- •- Cochlear implants
- •- Ferromagnetic implants
- •- Lying circumference above > MRI space capacity
研究者
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