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

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ClinicalTrials.gov Identifier: NCT02868619
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Obesity Other: Functional MRI Other: ADO-BEDS scale Other: R-CMAS scale Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 5, 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868619


Contacts
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Contact: Philippe COUBES 0467337375 p-coubes@chu-montpellier.fr
Contact: Fabienne CYPRIEN f-cyprien@chu-montpellier.fr

Locations
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France
Chu Montpellier Recruiting
Montpellier, France, 34295
Contact: Philippe COUBES    0467337375    p-coubes@chu-montpellier.fr   
Contact: Fabienne CYPRIEN       f-cyprien@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Fabienne CYPRIEN University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02868619     History of Changes
Other Study ID Numbers: 9093
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
fMRI
Deep brain stimulation
Food
Eating
Reward
Additional relevant MeSH terms:
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Obesity
Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive