Pediatric ObesityOBETEENNCT03776513
Neuro-cognitive Impact of Juvenile Obesity
A study testing an MRI examination in people with Pediatric Obesity and Behavior and Behavior Mechanisms, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Recent studies indicate that obese teenagers exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, necessary for the implementation of memory and emotional functions for the rest of life. Read more about this study
- Who is it for?
- Ages 12 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Behavior and Behavior Mechanisms, Emotions
- What is being tested?
- an MRI examination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2018to 19 Feb 2020
- 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 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Experimental group: 12-17 years old boys, BMI>30 (according to IOTF), right-handed, French secondary school, beneficiary of social security, consent of the holders of parental authority.
- Control group: 12-17 years old boys, BMI<25 (according to IOTF), right-handed, French secondary school, beneficiary of social security, consent of the holders of parental authority.
Who cannot join
- Adolescent with pubertal stage of Tanner <2
- Adolescent with known visual or auditory difficulties
- Adolescent with a known chronic pathology requiring medication
- Adolescent with psychotic, neurodevelopmental or substance use disorder
- Adolescent who may have a contraindication to the MRI examination (presence in the body of metallic prostheses, pacemaker, metal chips, claustrophobia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Juvenile Obesity on Emotional Memory and Functional Connectivity Between the Amygdala and the Hippocampus
Recent studies indicate that obese teenagers exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, necessary for the implementation of memory and emotional functions for the rest of life. Disturbances of the interaction between amygdala and hippocampus during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of juvenile obesity on functional amygdala-hippocampus connectivity has not been evaluated yet. The main objective of this study is to compare the emotional memory performance and the level of functional connectivity between the hippocampus and the amygdala during the realization of an emotional associative memory task, in obese and control adolescents.
Read the detailed description
Obesity increases the prevalence of cognitive impairment. In particular, it can promote disturbances of contextual memory dependent on the hippocampus. Obesity is also associated with negative emotional consequences. However, no clinical study has so far evaluated the effect of obesity on emotional memory, a function underpinned by the amygdala. Recent studies indicate that obese children and adolescents exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, two brain regions implicated in memory and emotional functions for the rest of life. Changes in connectivity during development, whether structural or functional, are major before the age of 10 and progressive and minor until the age of 30. Disturbances of this amygdala-hippocampal functional connectivity during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of childhood obesity on functional amygdala-hippocampus connectivity has still not been evaluated. The first aim of the study is to compare the functional connectivity of the hippocampus and the amygdala measured during the realization of an emotional associative memory task or at rest before and after the task between obese teenagers and control teenagers and how closely it is related to emotional memory performances. Secondly, it will be determined whether the level of functional connectivity between the hippocampus and the amygdala is related to cognitive performances and eating symptomatology in obese teenagers.
- Being tested
- an MRI examination
- Keywords
- obesity, teenagers, emotional memory, brain networks
- Medical subject headings
- Pediatric Obesity, Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an MRI examinationBehavioural
Also called a clinical and psychological examination and a series of cognitive tests
The MRI examination implies the realization of an emotional associative memory task
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Thirty obese boys (12-17 years old) undergoing an MRI, a clinical and psychological examination and a series of cognitive tests Receives: Behavioral: an MRI examination |
| control group | Other | Thirty healthy boys (12-17 years old) paired for pubertal stage, level of education and socio-economic level undergoing an MRI, a clinical and psychological examination and a series of cognitive tests Receives: Behavioral: an MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of connectivity between the amygdala and the hippocampus recorded during the execution of an emotional memory task in the scanner.
The level of connectivity between the hippocampus and the amygdala during the performance of the task will be measured through the fluctuations of the blood oxygen level-dependent (BOLD) signal obtained in activation functional magnetic resonance imaging (fMRI) during the performance of an associative emotional memory task. The level of functional connectivity between two brain regions will be deduced from the temporal correlation between the fluctuations of the BOLD signal between these two regions. This coefficient will be normalized in Z-score before analysis.
Measured: through study completion, an average of 24 months
Secondary outcomes (12)
The level of connectivity between the amygdala and the hippocampus before and after the task will also be recorded at rest.
The level of functional connectivity at rest will be measured before and after the task performed in the scanner. The fluctuations of the BOLD signal recorded at rest (while the subject is quietly resting eyes closed in the machine without being engaged in the performance of a task) also makes it possible to measure levels of functional connectivity of rest between two brain regions according to a method a little different from that applied to activation images (after filtering high frequencies). A Z-score reflecting the level of connectivity will be calculated before statistical analysis.
Measured: through study completion, an average of 24 months
The score at the emotional memory task performed in the scanner will be collected
The behavioral performance associated with the completion of the task is collected in an e-Prime file and expressed as percentages of correct answers.
Measured: through study completion, an average of 24 months
grey matter volumes (mm3)
The investigators will construct volumetric grey matter maps using Voxel-Based-Morphometry toolbox of SPM for each subject so as to conduct whole brain analysis.
Measured: through study completion, an average of 24 months
cortical thicknesses (mm)
The investigators will use FreeSurfer Suite to evaluate cortical thickness for each subject.
Measured: through study completion, an average of 24 months
The percentage of body fat
The percentage of body fat will be evaluated by a bio-impedancemetry scale that automatically provides a measure of body fat and lean mass.
Measured: through study completion, an average of 24 months
" Paired Associates Learning Task " administrated through the CANTAB neuropsychological examination
Paired Associates Learning assesses visual memory and new learning. Administration time: 8 minutes Task format: Boxes are displayed on the screen and are "opened" in a randomised order. One or more of them will contain a pattern. The patterns are then displayed in the middle of the screen, one at a time and the participant must select the box in which the pattern was originally located. If the participant makes an error, the boxes are opened in sequence again to remind the participant of the locations of the patterns. Increased difficulty levels can be used to test high-functioning, healthy individuals.
Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed.
Measured: through study completion, an average of 24 months
the number of distinct words for the free-recall phase (" Verbal Recall/Recognition Memory Task " administrated through the CANTAB neuropsychological examination)
Verbal Recognition Memory assesses verbal memory and new learning. It measures the ability to encode and subsequently retrieve verbal information, with recall tapping into fronto-temporal networks and recognition assessing hippocampal areas.
Administration time: 10 minutes Task format : The participant is shown a sequence of words on screen one by one. The participant is then tasked with recalling the words, whilst a rater marks which ones they remembered. In the next phase, the participant is presented with two words, one from the original list and one distractor and is asked to choose which one they have seen before, in a 2-force choice paradigm. The latter recognition phase is then repeated after a delay.
One of the outcome measures is the number of distinct words for the free-recall phase
Measured: through study completion, an average of 24 months
" Verbal Recall/Recognition Memory Task " administrated through the CANTAB neuropsychological examination
Verbal Recognition Memory assesses verbal memory and new learning. It measures the ability to encode and subsequently retrieve verbal information, with recall tapping into fronto-temporal networks and recognition assessing hippocampal areas.
Administration time: 10 minutes Task format : The participant is shown a sequence of words on screen one by one. The participant is then tasked with recalling the words, whilst a rater marks which ones they remembered. In the next phase, the participant is presented with two words, one from the original list and one distractor and is asked to choose which one they have seen before, in a 2-force choice paradigm. The latter recognition phase is then repeated after a delay.
The other outcome measures is the number of correct and incorrect responses for the immediate and delayed recognition parts of the test.
Measured: through study completion, an average of 24 months
Percentage of correct and incorrect responses at the " Emotion Recognition Task " administrated through the CANTAB neuropsychological examination
The Emotion Recognition Task (ERT) measures the ability to identify six basic emotions in facial expressions along a continuum of expression magnitude.
Administration time: 6-10 minutes Task format: Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise).
The first outcome measure for ERT is the percentages of correct and incorrect responses
Measured: through study completion, an average of 24 months
Number of correct or incorrect responses at the " Emotion Recognition Task " administrated through the CANTAB neuropsychological examination
The Emotion Recognition Task (ERT) measures the ability to identify six basic emotions in facial expressions along a continuum of expression magnitude.
Administration time: 6-10 minutes Task format: Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise).
The second outcome is the numbers of correct or incorrect response.
Measured: through study completion, an average of 24 months
Response latencies at the " Emotion Recognition Task " administrated through the CANTAB neuropsychological examination
The Emotion Recognition Task (ERT) measures the ability to identify six basic emotions in facial expressions along a continuum of expression magnitude.
Administration time: 6-10 minutes Task format: Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise).
The last outcome is the response latencies
Measured: through study completion, an average of 24 months
cognitive functioning of the adolescent
The cognitive functioning of the adolescent will also be evaluated by his parents through the raw scores on the 8 subscales of the BRIEF-C and on composite index (Behavioral Regulation Index and Metacognition Index), based on a set of the 8 raw scores.
Measured: through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start12 Dec 2018
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Why it stopped: target number of patient not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Equipe NeuroImagerie et Cognition Humaine CNRS UMR 5287 - INCIA, University of Bordeaux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776513
- Sponsor's protocol ID
- CHUBX 2017/19
- Acronym
- OBETEEN
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vertes PE, Bullmore ET. Annual research review: Growth connectomics--the organization and reorganization of brain networks during normal and abnormal development. J Child Psychol Psychiatry. 2015 Mar;56(3):299-320. doi: 10.1111/jcpp.12365. Epub 2014 Dec 1.
PubMed 25441756
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Juvenile Obesity on Emotional Memory and Functional Connectivity Between the Amygdala and the Hippocampus
- ClinicalTrials.gov ID
- NCT03776513
- Acronym / sponsor ID
- OBETEEN / CHUBX 2017/19
- Keywords
- obesity, teenagers, emotional memory, brain networks
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of patient not reached
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Equipe NeuroImagerie et Cognition Humaine CNRS UMR 5287 - INCIA, University of Bordeaux
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 14 Dec 2018 (actual)
- 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.
Recent studies indicate that obese teenagers exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, necessary for the implementation of memory and emotional functions for the rest of life. Disturbances of the interaction between amygdala and hippocampus during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of juvenile obesity on functional amygdala-hippocampus connectivity has not been evaluated yet. The main objective of this study is to compare the emotional memory performance and the level of functional connectivity between the hippocampus and the amygdala during the realization of an emotional associative memory task, in obese and control adolescents.
Detailed description
Obesity increases the prevalence of cognitive impairment. In particular, it can promote disturbances of contextual memory dependent on the hippocampus. Obesity is also associated with negative emotional consequences. However, no clinical study has so far evaluated the effect of obesity on emotional memory, a function underpinned by the amygdala. Recent studies indicate that obese children and adolescents exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, two brain regions implicated in memory and emotional functions for the rest of life. Changes in connectivity during development, whether structural or functional, are major before the age of 10 and progressive and minor until the age of 30. Disturbances of this amygdala-hippocampal functional connectivity during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of childhood obesity on functional amygdala-hippocampus connectivity has still not been evaluated. The first aim of the study is to compare the functional connectivity of the hippocampus and the amygdala measured during the realization of an emotional associative memory task or at rest before and after the task between obese teenagers and control teenagers and how closely it is related to emotional memory performances. Secondly, it will be determined whether the level of functional connectivity between the hippocampus and the amygdala is related to cognitive performances and eating symptomatology in obese teenagers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: an MRI examinationThirty obese boys (12-17 years old) undergoing an MRI, a clinical and psychological examination and a series of cognitive tests |
| control group | Other | Behavioral: an MRI examinationThirty healthy boys (12-17 years old) paired for pubertal stage, level of education and socio-economic level undergoing an MRI, a clinical and psychological examination and a series of cognitive tests |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Experimental group: 12-17 years old boys, BMI>30 (according to IOTF), right-handed, French secondary school, beneficiary of social security, consent of the holders of parental authority.
- Control group: 12-17 years old boys, BMI<25 (according to IOTF), right-handed, French secondary school, beneficiary of social security, consent of the holders of parental authority.
Key exclusion criteria (5 listed)
- Adolescent with pubertal stage of Tanner <2
- Adolescent with known visual or auditory difficulties
- Adolescent with a known chronic pathology requiring medication
- Adolescent with psychotic, neurodevelopmental or substance use disorder
- Adolescent who may have a contraindication to the MRI examination (presence in the body of metallic prostheses, pacemaker, metal chips, claustrophobia).
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 |
|---|---|---|
| an MRI examinationAlso: a clinical and psychological examination and a series of cognitive testsThe MRI examination implies the realization of an emotional associative memory task | Behavioural | control group, experimental group |
Primary outcome
the level of connectivity between the amygdala and the hippocampus recorded during the execution of an emotional memory task in the scanner.
Time frame: through study completion, an average of 24 months
The level of connectivity between the hippocampus and the amygdala during the performance of the task will be measured through the fluctuations of the blood oxygen level-dependent (BOLD) signal obtained in activation functional magnetic resonance imaging (fMRI) during the performance of an associative emotional memory task. The level of functional connectivity between two brain regions will be deduced from the temporal correlation between the fluctuations of the BOLD signal between these two regions. This coefficient will be normalized in Z-score before analysis.
12 secondary outcomes
The level of connectivity between the amygdala and the hippocampus before and after the task will also be recorded at rest.
Time frame: through study completion, an average of 24 months
The score at the emotional memory task performed in the scanner will be collected
Time frame: through study completion, an average of 24 months
grey matter volumes (mm3)
Time frame: through study completion, an average of 24 months
cortical thicknesses (mm)
Time frame: through study completion, an average of 24 months
The percentage of body fat
Time frame: through study completion, an average of 24 months
" Paired Associates Learning Task " administrated through the CANTAB neuropsychological examination
Time frame: through study completion, an average of 24 months
the number of distinct words for the free-recall phase (" Verbal Recall/Recognition Memory Task " administrated through the CANTAB neuropsychological examination)
Time frame: through study completion, an average of 24 months
" Verbal Recall/Recognition Memory Task " administrated through the CANTAB neuropsychological examination
Time frame: through study completion, an average of 24 months
Percentage of correct and incorrect responses at the " Emotion Recognition Task " administrated through the CANTAB neuropsychological examination
Time frame: through study completion, an average of 24 months
Number of correct or incorrect responses at the " Emotion Recognition Task " administrated through the CANTAB neuropsychological examination
Time frame: through study completion, an average of 24 months
Response latencies at the " Emotion Recognition Task " administrated through the CANTAB neuropsychological examination
Time frame: through study completion, an average of 24 months
cognitive functioning of the adolescent
Time frame: through study completion, an average of 24 months
Results and safety
The study was stopped early (reason given: target number of patient not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: PubMed 25441756Vertes PE, Bullmore ET. Annual research review: Growth connectomics--the organization and reorganization of brain networks during normal and abnormal development. J Child Psychol Psychiatry. 2015 Mar;56(3):299-320. doi: 10.1111/jcpp.12365. Epub 2014 Dec 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an MRI examination in people with Pediatric Obesity and Behavior and Behavior Mechanisms, run by University Hospital, Bordeaux 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Jun 2026. 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 was stopped early (reason given: target number of patient not reached). Results are not available in the source record.
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?
the level of connectivity between the amygdala and the hippocampus recorded during the execution of an emotional memory task in the scanner. (time frame: through study completion, an average of 24 months). 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 NCT03776513, which also lists 1 linked publication.
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 23 Jun 2026.