Binge Eating Disorder and Obesity : Functional MRI Study

NCT02868619 | Completed

• 1 other identifier: 9093
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating Disorder; Obesity

Keywords

fMRI; Deep brain stimulation; Food; Eating; Reward

Outcome Measures

Primary Outcomes (1)

• 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).

  4 years

Secondary Outcomes (1)

• Pairwise comparisons in neural activation assessed during functional MRI

  4 years

Study Arms (2)

Healthy controls

OTHER

Non obese adolescents without Binge Eating Disorder (BED)

Other: Functional MRI; Other: ADO-BEDS scale; Other: R-CMAS scale

Patients with BED

OTHER

Obese adolescents with BED with Binge Eating Disorder (BED)

Other: Functional MRI; Other: ADO-BEDS scale; Other: R-CMAS scale

Interventions

Functional MRI OTHER

functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety

Healthy controls; Patients with BED

ADO-BEDS scale OTHER

Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria

Healthy controls; Patients with BED

R-CMAS scale OTHER

Evaluate the anxiety

Healthy controls; Patients with BED

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Chu Montpellier

Montpellier, 34295, France

Location

Related Publications (2)

• 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.

  PMID: 33484819 DERIVED

• 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.

  PMID: 31982461 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabienne CYPRIEN

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 16, 2016
• Study Start: December 5, 2014
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)