NCT03776513

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
1 month until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
Last Updated

June 23, 2026

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

November 7, 2018

Last Update Submit

June 18, 2026

Conditions

Keywords

obesity, teenagers, emotional memory, brain networks

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

EXPERIMENTAL

Thirty obese boys (12-17 years old) undergoing an MRI, a clinical and psychological examination and a series of cognitive tests

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

Behavioral: an MRI examination

Interventions

The MRI examination implies the realization of an emotional associative memory task

Also known as: a clinical and psychological examination and a series of cognitive tests
control groupexperimental group

Eligibility Criteria

Age12 Years - 17 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

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.

MeSH Terms

Conditions

Pediatric ObesityBehaviorObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations