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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Contact Information
Primary
Esther Via, PhD
evia@hsjdbcn.es
+34 673342094
Time Frame
Start Date: 2023-07-21
Estimated Completion Date: 2026-05
Participants
Target number of participants: 102
Treatments
Control group (CG)
Adolescents with obesity, measured as body mass index (BMI) z-score above 2 standard deviations, and no BED/PREC-BED
BED group
adolescents with obesity, measured as BMI z-score above 2 standard deviations, and BED
PREC-BED group
adolescents with obesity, measured as BMI z-score above 2 standard deviations, PREC-BED
Related Therapeutic Areas
Sponsors
Leads: Fundació Sant Joan de Déu
Collaborators: Instituto de Salud Carlos III

This content was sourced from clinicaltrials.gov