Actively Recruiting

Age: 12Years - 16Years
All Genders
NCT06387719

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

Led by Fundació Sant Joan de Déu · Updated on 2024-04-29

102

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

Sponsors

F

Fundació Sant Joan de Déu

Lead Sponsor

I

Instituto de Salud Carlos III

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred to the Endocrinology Department with obesity, defined as BMI z-score above 2 standard deviations
  • Age between 12 and 16 years old
  • Signed informed consent by parents or legal guardians and assent by adolescents aged 12 or older
  • For BED group: Must meet DSM-5 criteria for binge eating disorder
  • For PREC-BED group: Must meet loss of control (LOC) criteria related to original Marcus & Kalarchian definition
Not Eligible

You will not qualify if you...

  • Intelligence quotient below 70 measured with the K-BIT test
  • Any psychiatric disorder except BED in the BED group or PREC-BED in the PREC-BED group; tobacco use and mild anxiety or adaptive disorders allowed
  • History of traumatic brain injury or neurological disorders
  • Use of dental braces due to MRI artifact interference
  • MRI contraindications such as metal objects or claustrophobia; weight over 150 kg or shoulder width over 70 cm
  • Severe medical conditions including sleep apnea-hypopnea syndrome, except obesity and metabolic syndrome
  • Lack of signed informed consent
  • Pregnancy for female participants

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain, 08950

Actively Recruiting

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Research Team

E

Esther Via, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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