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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

Tracking Information
First Submitted Date  ICMJE August 8, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date November 30, 2018
Actual Study Start Date  ICMJE December 5, 2014
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
Differences in neural activation assessed during funtional 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 reponse 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).
Change History Complete list of historical versions of study NCT02868619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Binge Eating Disorder and Obesity : Functional MRI Study
Official Title  ICMJE Binge Eating Disorder and Obesity : Reward System Abnormalities in Response to Food Stimuli and Research Operability by Deep Brain Stimulation Criteria: Functional MRI Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Binge Eating Disorder
  • Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Healthy controls
    Non obese adolescents without Binge Eating Disorder (BED)
    Interventions:
    • Other: Functional MRI
    • Other: ADO-BEDS scale
    • Other: R-CMAS scale
  • Patients with BED
    Obese adolescents with BED with Binge Eating Disorder (BED)
    Interventions:
    • Other: Functional MRI
    • Other: ADO-BEDS scale
    • Other: R-CMAS scale
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2016)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Philippe COUBES 0467337375 p-coubes@chu-montpellier.fr
Contact: Fabienne CYPRIEN f-cyprien@chu-montpellier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02868619
Other Study ID Numbers  ICMJE 9093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fabienne CYPRIEN University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP