Binge Eating DisorderBEDNCT02868619
Binge Eating Disorder and Obesity : Functional MRI Study
A study testing Functional MRI, ADO-BEDS scale and R-CMAS scale in people with Binge Eating Disorder and Obesity, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder, Obesity
- What is being tested?
- Functional MRI, ADO-BEDS scale and R-CMAS scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2014to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- The existence of possible psychiatric histories will be individually estimated
- Pregnancy and breastfeeding
- Loss of liberty by court or administrative order
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Binge Eating Disorder, Obesity
- Being tested
- Functional MRI, ADO-BEDS scale, R-CMAS scale
- Keywords
- fMRI, Deep brain stimulation, Food, Eating, Reward
- Medical subject headings
- Binge-Eating Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRIOther
functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety
ADO-BEDS scaleOther
Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria
R-CMAS scaleOther
Evaluate the anxiety
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | Non obese adolescents without Binge Eating Disorder (BED) Receives: Other: Functional MRI; Other: ADO-BEDS scale; Other: R-CMAS scale |
| Patients with BED | Other | Obese adolescents with BED with Binge Eating Disorder (BED) Receives: Other: Functional MRI; Other: ADO-BEDS scale; Other: R-CMAS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 years
Secondary outcomes (1)
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start5 Dec 2014
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne CYPRIEN, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868619
- Sponsor's protocol ID
- 9093
- Acronym
- BED
- Status last verified
- May 2021
- First submitted
- 8 Aug 2016
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33484819Charroud 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.
PubMed 31982461
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02868619
- Acronym / sponsor ID
- BED / 9093
- Conditions
- Binge Eating Disorder, Obesity
- Keywords
- fMRI, Deep brain stimulation, Food, Eating, Reward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Dec 2014 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Other | Other: Functional MRI, Other: ADO-BEDS scale, Other: R-CMAS scaleNon obese adolescents without Binge Eating Disorder (BED) |
| Patients with BED | Other | Other: Functional MRI, Other: ADO-BEDS scale, Other: R-CMAS scaleObese adolescents with BED with Binge Eating Disorder (BED) |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Non specific inclusion criteria
- Specific inclusion criteria for the patients
- Specific inclusion criteria for the volunteers
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRIfunctional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety | Other | Healthy controls, Patients with BED |
| ADO-BEDS scaleEvaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria | Other | Healthy controls, Patients with BED |
| R-CMAS scaleEvaluate the anxiety | Other | Healthy controls, Patients with BED |
Primary outcome
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).
1 secondary outcome
Pairwise comparisons in neural activation assessed during functional MRI
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 33484819Charroud 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.
- Derived from this study: PubMed 31982461Charroud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne CYPRIEN principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional MRI, ADO-BEDS scale and R-CMAS scale in people with Binge Eating Disorder and Obesity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in neural activation assessed during functional MRI (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868619, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.