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Binge Eating Disorder and Obesity : Functional MRI Study (BED)

Primary Purpose

Binge Eating Disorder, Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional MRI
ADO-BEDS scale
R-CMAS scale
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Binge Eating Disorder focused on measuring fMRI, Deep brain stimulation, Food, Eating, Reward

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Non specific inclusion criteria

    • Age limits ≥ 12 et < 16 years
    • Collection of the informed consent. For the minor patients, signature of parents
    • Affiliation or recipient with the mode of social security.
    • No associated evolutionary pathologies

  • Specific inclusion criteria for the patients

    • Existence of a current food disorder of the conducts of type binge eating disorder according to the criteria Marcus and Kalarchian
    • Diagnosis of obesity defined by a body mass index > 97th percentile
    • Severity criteria defined by: Evolution of the obesity and the BED for at least 5 years AND Not answer to a dietary, pharmacological, psychotherapeutic care during at least 6 months

  • Specific inclusion criteria for the volunteers

    • Absence of a current food disorder of the conducts of type binge eating disorder according to the criteria Marcus and Kalarchian
    • Absence of antecedent of neurological disorder
    • an actual body mass index < 90th percentile

Exclusion Criteria:

  • IRM contraindication
  • Pacemaker
  • Port(Bearing) of surgical clips in the cervico-cephalic region or implanted medical surgical material(equipment) susceptible to mobilize under the influence of magnetic gradients
  • Intraocular foreign body
  • Metalic foreign body
  • claustrophobia
  • The existence of possible psychiatric histories will be individually estimated
  • Pregnancy and breastfeeding
  • Loss of liberty by court or administrative order

Sites / Locations

  • Chu Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy controls

Patients with BED

Arm Description

Non obese adolescents without Binge Eating Disorder (BED)

Obese adolescents with BED with Binge Eating Disorder (BED)

Outcomes

Primary Outcome Measures

Differences in neural activation assessed during functional MRI
The main objective of this study is the identification in patients with obesity and Binge Eating Disorder (BED) of functional MRI activation profiles (reward system) in response to food stimuli. The activation profiles will be analyzed by varying physiological conditions of hunger and satiety, and motivational value attributed to the food (calorie).

Secondary Outcome Measures

Pairwise comparisons in neural activation assessed during functional MRI
Further pairwise comparisons in neural activation assessed during functional MRI help to define DBS indication criteria / operability for BED obese candidates.

Full Information

First Posted
August 8, 2016
Last Updated
May 14, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02868619
Brief Title
Binge Eating Disorder and Obesity : Functional MRI Study
Acronym
BED
Official Title
Binge Eating Disorder and Obesity : Reward System Abnormalities in Response to Food Stimuli and Research Operability by Deep Brain Stimulation Criteria: Functional MRI Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2014 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity, defined as BMI> 30kg / m2, is a major public health problem, with devastating medical and psychological consequences. 30% of obese suffer from BED type of eating disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of cases. Many arguments are in favor of the involvement of the reward circuitry, with the central role of NAc in the pathophysiology of BED and obesity. The recent application and effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest that DBS may be of interest in treating obesity and BED with potential target for the NAc. This project propose to study fMRI activation of the reward system in response to food stimuli to better direct the DBS targets. This is a pilot study to define indication criteria based on fMRI to obese BED patients are potential candidates for treatment with DBS.
Detailed Description
The aim of this functional neuroimaging study is to analyze brain responses to visual food cues in obese (body mass index > 97th percentile) adolescents with BED (according to the criteria Marcus and Kalarchian) compared with healthy control adolescents in two situations : hunger et satiety. Fifteen obese adolescents (12/16 years) with BED and fifteen healthy control adolescents will be enrolled in the study protocol. Participants will be instructed not to eat food for at least 6 hours prior to the first imaging session. After the initial set of functional and anatomic scans, participants will be fed a standard calorie meal. Approximately 1 hour later, the experiment will be repeated while participants are in a satiated condition. The cortical fMRI activation will be measured during the following four experimental visual conditions : high calory food, low calory food, disgust and neutral presented in block design. First-level and second-level differences in neural activation assessed during functional MRI in the different conditions will then be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Obesity
Keywords
fMRI, Deep brain stimulation, Food, Eating, Reward

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Other
Arm Description
Non obese adolescents without Binge Eating Disorder (BED)
Arm Title
Patients with BED
Arm Type
Other
Arm Description
Obese adolescents with BED with Binge Eating Disorder (BED)
Intervention Type
Other
Intervention Name(s)
Functional MRI
Intervention Description
functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety
Intervention Type
Other
Intervention Name(s)
ADO-BEDS scale
Intervention Description
Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria
Intervention Type
Other
Intervention Name(s)
R-CMAS scale
Intervention Description
Evaluate the anxiety
Primary Outcome Measure Information:
Title
Differences in neural activation assessed during functional MRI
Description
The main objective of this study is the identification in patients with obesity and Binge Eating Disorder (BED) of functional MRI activation profiles (reward system) in response to food stimuli. The activation profiles will be analyzed by varying physiological conditions of hunger and satiety, and motivational value attributed to the food (calorie).
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Pairwise comparisons in neural activation assessed during functional MRI
Description
Further pairwise comparisons in neural activation assessed during functional MRI help to define DBS indication criteria / operability for BED obese candidates.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non specific inclusion criteria Age limits ≥ 12 et < 16 years Collection of the informed consent. For the minor patients, signature of parents Affiliation or recipient with the mode of social security. No associated evolutionary pathologies Specific inclusion criteria for the patients Existence of a current food disorder of the conducts of type binge eating disorder according to the criteria Marcus and Kalarchian Diagnosis of obesity defined by a body mass index > 97th percentile Severity criteria defined by: Evolution of the obesity and the BED for at least 5 years AND Not answer to a dietary, pharmacological, psychotherapeutic care during at least 6 months Specific inclusion criteria for the volunteers Absence of a current food disorder of the conducts of type binge eating disorder according to the criteria Marcus and Kalarchian Absence of antecedent of neurological disorder an actual body mass index < 90th percentile Exclusion Criteria: IRM contraindication Pacemaker Port(Bearing) of surgical clips in the cervico-cephalic region or implanted medical surgical material(equipment) susceptible to mobilize under the influence of magnetic gradients Intraocular foreign body Metalic foreign body claustrophobia The existence of possible psychiatric histories will be individually estimated Pregnancy and breastfeeding Loss of liberty by court or administrative order
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne CYPRIEN
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33484819
Citation
Charroud C, Poulen G, Sanrey E, Menjot de Champfleur N, Deverdun J, Coubes P, Le Bars E. Task- and Rest-based Functional Brain Connectivity in Food-related Reward Processes among Healthy Adolescents. Neuroscience. 2021 Mar 1;457:196-205. doi: 10.1016/j.neuroscience.2021.01.016. Epub 2021 Jan 21.
Results Reference
derived
PubMed Identifier
31982461
Citation
Charroud C, Menjot de Champfleur N, Sanrey E, Pfeuffer J, Deverdun J, Le Bars E, Coubes P. Differential effects of hunger on cerebral blood flow in healthy adolescents. Behav Brain Res. 2020 Apr 6;383:112505. doi: 10.1016/j.bbr.2020.112505. Epub 2020 Jan 23.
Results Reference
derived

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Binge Eating Disorder and Obesity : Functional MRI Study

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