fMRI Study of Emotion Regulation in Patients Suffering From Obesity With or Without Binge Eating Disorder and Seeking Bariatric Surgery

NCT ID: NCT05131256

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2025-07-20

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.

Conditions

Obesity; Binge-Eating Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

patients suffering from obesity with BED

Group Type: EXPERIMENTAL

Neurofunctional characterization of emotional regulation (fMRI)

Intervention Type: BEHAVIORAL

Investigation of neurofunctional characterization of emotional regulation and its links with the eating behaviours of patients suffering from obesity using a comprehensive, clinical, and cognitive assessment and task-based MRI exams.

patients suffering from obesity without BED

Group Type: ACTIVE_COMPARATOR

Neurofunctional characterization of emotional regulation (fMRI)

Intervention Type: BEHAVIORAL

Investigation of neurofunctional characterization of emotional regulation and its links with the eating behaviours of patients suffering from obesity using a comprehensive, clinical, and cognitive assessment and task-based MRI exams.

healthy participants

Group Type: ACTIVE_COMPARATOR

Neurofunctional characterization of emotional regulation (fMRI)

Intervention Type: BEHAVIORAL

Investigation of neurofunctional characterization of emotional regulation and its links with the eating behaviours of patients suffering from obesity using a comprehensive, clinical, and cognitive assessment and task-based MRI exams.

Interventions

Neurofunctional characterization of emotional regulation (fMRI)

Investigation of neurofunctional characterization of emotional regulation and its links with the eating behaviours of patients suffering from obesity using a comprehensive, clinical, and cognitive assessment and task-based MRI exams.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• 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

• 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.

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damien JOLLY

Reims, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Farid BENZEROUK

Role: CONTACT

fbenzerouk@chu-reims.fr

03 26 78 33 94 ext. 0033

Facility Contacts

Farid BENZEROUK

Role: primary

fbenzerouk@chu-reims.fr

03 26 78 33 94 ext. 0033

Other Identifiers

PJ20148

Identifier Type: -

Identifier Source: org_study_id