Neurofunctional Characterization of Emotional Regulation and Its Links With the Eating Behaviour of Patients Suffering From Obesity, With or Without Binge Eating Disorder and Seeking Bariatric Surgery. Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- fMRI activations during an emotional regulation task (a cognitive reappraisal task)
研究概览
简要总结
Obesity is a major public health problem and Binge eating disorder (BED) is very frequently observed in patients considered for weight loss surgery and seems to influence their outcome critically. Literature highlights a global emotional overload in individuals with BED, but few are known on the mechanisms involved. The purpose of this study is to fill this gap by comparing the neurofunctional profiles of emotion regulation between patients suffering from obesity, with or without BED and healthy participants during the performance of emotion regulation tasks. Results may help to understand the neural bases of the impairments observed in patients with obesity, with or without BED, which may in turn help to propose, in the long term, potential new therapeutic approaches.
详细描述
Obesity is a major public health problem and frequently associated with Binge eating disorder (BED) in patients considered for weight loss surgery and seems to influence their outcome critically. It may be due, in part, to an ineffective or a maladaptive emotional regulation. Emotion regulation is the ability to exert control over one's own emotional state. The relative absence of this ability would indicate the presence of difficulties in emotion regulation, or an emotion dysregulation. Individuals with disordered eating may have a greater vulnerability to use maladaptive emotion regulation strategies. In the eating behaviours, an emotion dysregulation can cause weight gain that can lead to overweight or obesity. Accordingly, patients suffering from obesity, and with BED may have a greater vulnerability to use maladaptive emotion regulation strategies. However, few studies have investigated the neurofunctional profiles of emotion regulation in patients suffering from obesity with and without BED and seeking bariatric surgery.
The aim of the study is to explore the neural correlates of emotion regulation in patients suffering from obesity, with or without BED, in comparison with those of healthy participants. We also aim to describe the relationship between the neural correlates, eating behaviours and assessed psychological profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Patients suffering from obesity, seeking bariatric surgery, and with BED.
- •Inclusion criteria:
- •Patients between 18 and 60 years old, men or women, right-handed
- •Having a diagnosis of obesity class 2 or 3 and seeking bariatric surgery
- •With Binge eating disorder (BED)
- •Possibility to the use of MRI
- •Patients being a native French speaker
- •Patients enrolled in the national healthcare insurance program
- •Patients consenting to participate to the study
排除标准
- •The presence of a current substance use disorder as defined by DSM-5 criteria
- •The presence of neurological disorders or head trauma
- •The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- •A current mood episode as defined by DSM-5 criteria
- •A diagnosis of schizophrenia or of bipolar disorder according to DSM-5 criteria
- •Handling of psychotropics substances
- •A sensorial impairment uncorrected (visual and/or hearing)
- •Contraindication to the use of MRI
- •Pregnant woman and people particularly protected by the law
- •Group 2: Patients suffering from obesity, seeking bariatric surgery, and without BED.
- •Inclusion criteria:
- •Patients between 18 and 60 years old, men or women, right-handed
- •Having a diagnosis of obesity class 2 or 3 and seeking bariatric surgery
- •Without Binge eating disorder (BED)
- •Possibility to the use of MRI
- •Patients being a native French speaker
- •Patients enrolled in the national healthcare insurance program
- •Patients consenting to participate to the study
- •Exclusion criteria:
- •The presence of a current substance use disorder as defined by DSM-5 criteria
- •The presence of neurological disorders or head trauma
- •The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- •A current mood episode as defined by DSM-5 criteria
- •A diagnosis of schizophrenia or of bipolar disorder according to DSM-5 criteria
- •Handling of psychotropics substances
- •A sensorial impairment uncorrected (visual and/or hearing)
- •Contraindication to the use of MRI
- •Pregnant woman and people particularly protected by the law
- •Group 3: Healthy participants.
- •Inclusion criteria:
- •Men or women, right-handed, between 18 and 60 years old
- •Without overweight nor obesity
- •Native French speaker
- •Individuals enrolled in the national healthcare insurance program
- •Individuals consenting to participate to the study
- •Exclusion criteria:
- •Past obesity
- •The presence of neurological disorders or head trauma
- •The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- •Handling of psychotropics substances
- •A sensorial impairment uncorrected (visual and/or hearing)
- •Contraindication to the use of MRI
- •Pregnant woman and people particularly protected by the law
- •A current mood episode as defined by DSM-5 criteria
- •A diagnosis of schizophrenia or of bipolar disorder according to DSM-5 criteria
- •The presence of a current substance use disorder as defined by DSM-5 criteria
- •A diagnosis of eating disorder as defined by DSM-5 criteria
研究组 & 干预措施
healthy participants
干预措施: Neurofunctional characterization of emotional regulation (fMRI) (Behavioral)
patients suffering from obesity with BED
干预措施: Neurofunctional characterization of emotional regulation (fMRI) (Behavioral)
patients suffering from obesity without BED
干预措施: Neurofunctional characterization of emotional regulation (fMRI) (Behavioral)
结局指标
主要结局
fMRI activations during an emotional regulation task (a cognitive reappraisal task)
时间窗: Day 0
The participant either reappraises or passively watches negative or neutral pictures and rates his affect (visual analogue scale: 0 to 10, high scores mean negative feelings).
fMRI activations during the inhibition of an ongoing motor response under an emotional condition (emotional stop signal task)
时间窗: Day 0
The participant is presented with a series of images comprised of neutral, positive, and negative categories and is instructed to categorize the images according to their valence (Go trials). Some trials include a stop signal indicating that the participant should inhibit his behavioral response and associated emotional reaction (Stop trials).
fMRI activations during the performance of an emotion regulation task (an emotional Stroop task)
时间窗: Day 0
The participant is asked to count how many numbers are presented on the screen. Numbers may match the value of the number (congruent condition) or not (incongruent condition). The numbers are preceded by emotional stimuli (negative, positive, neutral). The participant also views the emotional stimuli pictures without counting numbers (view condition).
次要结局
- Description of eating behaviours: Emotional eating, external eating, restraint eating(Day 0)
- Description of eating behaviours: Bulimic symptomatology(Day 0)
- Description of psychological profiles (emotional, cognitive and personality): Depression severity(Day 0)
- Description of eating behaviours: Binge eating(Day 0)
- Description of psychological profiles (emotional, cognitive and personality): Emotion regulation(Day 0)
- Description of psychological profiles (emotional, cognitive and personality): Anxiety severity(Day 0)
- Description of psychological profiles (emotional, cognitive and personality): Impulsivity(Day 0)