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RECRUITINGOBSERVATIONAL

Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity

Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity: Early MRI Markers of Brain Reward and Inhibition Processing Dysfunction

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients derived to the Endocrinology Department with obesity as the main criterion for consultation, measured as body mass index (BMI) z-score above 2 standard deviations. - Age between 12-16 years old. - Signed willing to sign a consent form by parents or legal guardians of subjects, plus the signed consent by the adolescent when being 12 or older years/old. Additional inclusion criteria for the BED and PREC-BED groups: - The presence of DSM-5 criteria for BED in the BED group. - Fulfilling the LOC (loss of control) criteria (related to the original Marcus\&Kalarchian) in the PREC-BED group. Who Should NOT Join This Trial: - Intelligence quotient \< 70 measured with the K-BIT. - Any comorbid psychiatric disorder, except BED in the BED group or PREC-BED in the PREC-BED group. Tobacco use and the presence of an adaptative disorder or any mild anxiety disorder will be accepted in all groups. - Traumatic brain injury or any neurological disorder. - Use of dental braces (due to important artifact in MRI). - MRI: Absolute contraindications (e.g.: metal objects), relative contraindications (claustrophobia). Anthropometric measures: Weight \> 150Kg or shoulder to shoulder measurement \> 70 cm. - Any severe medical conditions (including Sleep apnea-hypopnea syndrome), except for obesity and metabolic syndrome. - Not signing the willing to sign a consent form. - Pregnancy for females. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients derived to the Endocrinology Department with obesity as the main criterion for consultation, measured as body mass index (BMI) z-score above 2 standard deviations. * Age between 12-16 years old. * Signed informed consent by parents or legal guardians of subjects, plus the signed consent by the adolescent when being 12 or older years/old. Additional inclusion criteria for the BED and PREC-BED groups: * The presence of DSM-5 criteria for BED in the BED group. * Fulfilling the LOC (loss of control) criteria (related to the original Marcus\&Kalarchian) in the PREC-BED group. Exclusion Criteria: * Intelligence quotient \< 70 measured with the K-BIT. * Any comorbid psychiatric disorder, except BED in the BED group or PREC-BED in the PREC-BED group. Tobacco use and the presence of an adaptative disorder or any mild anxiety disorder will be accepted in all groups. * Traumatic brain injury or any neurological disorder. * Use of dental braces (due to important artifact in MRI). * MRI: Absolute contraindications (e.g.: metal objects), relative contraindications (claustrophobia). Anthropometric measures: Weight \> 150Kg or shoulder to shoulder measurement \> 70 cm. * Any severe medical conditions (including Sleep apnea-hypopnea syndrome), except for obesity and metabolic syndrome. * Not signing the informed consent. * Pregnancy for females.

Treatments Being Tested

DIAGNOSTIC_TEST

Magnetic resonance imaging

* Basic sequence for ethical consideration: evaluation of casual findings. * Structural MRI. * Functional MRI (fMRI) in the Resting-state * fMRI- task based. Presented in a computer screen on a magnetically compatible googles.

Locations (1)

Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain