Clinical trial NCT05131256: fMRI Study of Emotion Regulation in Patients Suffering From Obesity With or Without Binge Eating Disorder and Seeking Bariatric Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Binge-Eating Disorder
Keywords: Obesity
Emotion
fMRI
Emotion regulation
Binge eating disorder
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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 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

Primary outcomes:
measure: fMRI activations during an emotional regulation task (a cognitive reappraisal task)
timeFrame: Day 0
measure: fMRI activations during the inhibition of an ongoing motor response under an emotional condition (emotional stop signal task)
timeFrame: Day 0
measure: fMRI activations during the performance of an emotion regulation task (an emotional Stroop task)
timeFrame: Day 0
Secondary outcomes:
measure: Description of eating behaviours: Binge eating
timeFrame: Day 0
measure: Description of eating behaviours: Emotional eating, external eating, restraint eating
timeFrame: Day 0
measure: Description of eating behaviours: Bulimic symptomatology
timeFrame: Day 0
measure: Description of psychological profiles (emotional, cognitive and personality): Emotion regulation
timeFrame: Day 0
measure: Description of psychological profiles (emotional, cognitive and personality): Depression severity
timeFrame: Day 0
measure: Description of psychological profiles (emotional, cognitive and personality): Anxiety severity
timeFrame: Day 0
measure: Description of psychological profiles (emotional, cognitive and personality): Impulsivity
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: