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Recruiting NCT06387719

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

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Trial Parameters

Condition Binge-Eating Disorder
Sponsor Fundació Sant Joan de Déu
Study Type OBSERVATIONAL
Phase N/A
Enrollment 102
Sex ALL
Min Age 12 Years
Max Age 16 Years
Start Date 2023-07-21
Completion 2025-03
Interventions
Magnetic resonance imaging

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Brief Summary

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.

Eligibility Criteria

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 arti

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