跳至主要内容
临床试验/NCT03454711
NCT03454711已完成2 期

Functional Magnetic Resonance Imaging (fMRI) Exploration of Neurocognitive Processes Involved in Food Addiction (FA) in Obese Patients: Towards New Phenotypic Markers for an Optimized Care Pathway

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年4月26日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
47
试验地点
2
主要终点
Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI during a cognitive task based on food choice making

研究概览

简要总结

Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making

详细描述

Obesity is a worldwide epidemic associated with many complications. The treatment of obesity is a failure if it does not take into account eating disorders. Among them, food addictions seem to be frequent among obese patients. Clinical diagnosis and therapeutic approaches depend on presence of these FA. Moreover, eating disorders are associated with visible brain abnormalities in fMRI but the cerebral fMRI phenotype of FA is not known.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • right-handed
  • grade 1 and 2 obesity
  • aged between 20 and 50
  • no other addictions including smoking
  • no contraindications to fMRI
  • affiliated to French Social Security
  • having given a written informed consent

排除标准

  • abdominal circumference + upper limbs along the body > 200cm
  • addiction to alcohol or other psychoactive substances
  • daily smoker
  • sleep Apnea Syndrome paired
  • psychotic psychiatric disorders
  • history of bariatric surgery
  • medical care in the nutrition unit
  • inability to comprehend or complete questionnaires
  • pregnant or breastfeeding woman
  • persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

结局指标

主要结局

Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI during a cognitive task based on food choice making

时间窗: Month 2

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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