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

May 14, 2021 updated by: University Hospital, Montpellier

Binge Eating Disorder and Obesity : Reward System Abnormalities in Response to Food Stimuli and Research Operability by Deep Brain Stimulation Criteria: Functional MRI Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy controls
Non obese adolescents without Binge Eating Disorder (BED)
Other: Functional MRI
functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety
Other: ADO-BEDS scale
Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria
Other: R-CMAS scale
Evaluate the anxiety
Other: Patients with BED
Obese adolescents with BED with Binge Eating Disorder (BED)
Other: Functional MRI
functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety
Other: ADO-BEDS scale
Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria
Other: R-CMAS scale
Evaluate the anxiety

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in neural activation assessed during functional MRI
Time Frame: 4 years
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).
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pairwise comparisons in neural activation assessed during functional MRI
Time Frame: 4 years
Further pairwise comparisons in neural activation assessed during functional MRI help to define DBS indication criteria / operability for BED obese candidates.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Fabienne CYPRIEN, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2014

Primary Completion (Actual)

March 10, 2021

Study Completion (Actual)

March 10, 2021

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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