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

NCT05131256 | Unknown

• 1 other identifier: PJ20148
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Binge-Eating Disorder

Keywords

Obesity; Emotion; fMRI; Emotion regulation; Binge eating disorder

Outcome Measures

Primary Outcomes (3)

• fMRI activations during an emotional regulation task (a cognitive reappraisal task)

  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).

  Day 0

• fMRI activations during the inhibition of an ongoing motor response under an emotional condition (emotional stop signal task)

  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).

  Day 0

• fMRI activations during the performance of an emotion regulation task (an emotional Stroop task)

  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).

  Day 0

Secondary Outcomes (7)

• Description of eating behaviours: Binge eating

  Day 0

• 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): Emotion regulation

  Day 0

• Description of psychological profiles (emotional, cognitive and personality): Depression severity

  Day 0

Study Arms (3)

patients suffering from obesity with BED

EXPERIMENTAL

Behavioral: Neurofunctional characterization of emotional regulation (fMRI)

patients suffering from obesity without BED

ACTIVE COMPARATOR

Behavioral: Neurofunctional characterization of emotional regulation (fMRI)

healthy participants

ACTIVE COMPARATOR

Behavioral: Neurofunctional characterization of emotional regulation (fMRI)

Interventions

Neurofunctional characterization of emotional regulation (fMRI) 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; patients suffering from obesity with BED; patients suffering from obesity without BED

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Obesity; Binge-Eating Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Farid BENZEROUK

CONTACT

03 26 78 33 94; fbenzerouk@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: November 23, 2021
• Study Start: July 20, 2022
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

FR (1)