RecruitingNCT06387719

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


Sponsor

Fundació Sant Joan de Déu

Enrollment

102 participants

Start Date

Jul 21, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 12 YearsMax Age: 16 Years

Inclusion Criteria5

  • 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.
  • 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 Criteria8

  • 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.

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Interventions

DIAGNOSTIC_TESTMagnetic 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

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NCT06387719


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