Study Stopped
target number of patient not reached
Neuro-cognitive Impact of Juvenile Obesity
OBETEEN
Impact of Juvenile Obesity on Emotional Memory and Functional Connectivity Between the Amygdala and the Hippocampus
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2018
CompletedStudy Start
First participant enrolled
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2020
CompletedJune 23, 2026
November 1, 2018
1.2 years
November 7, 2018
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
through study completion, an average of 24 months
The score at the emotional memory task performed in the scanner will be collected
through study completion, an average of 24 months
grey matter volumes (mm3)
through study completion, an average of 24 months
cortical thicknesses (mm)
through study completion, an average of 24 months
The percentage of body fat
through study completion, an average of 24 months
- +7 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALThirty obese boys (12-17 years old) undergoing an MRI, a clinical and psychological examination and a series of cognitive tests
control group
OTHERThirty 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
Interventions
The MRI examination implies the realization of an emotional associative memory task
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bordeaux University Hospital
Bordeaux, 33079, France
Related Publications (1)
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.
PMID: 25441756RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2018
First Posted
December 14, 2018
Study Start
December 12, 2018
Primary Completion
February 19, 2020
Study Completion
February 19, 2020
Last Updated
June 23, 2026
Record last verified: 2018-11