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Clinical Trials/NCT05149859
NCT05149859
Recruiting
Not Applicable

Reconsidering Severity Classification for Binge Eating Disorder (BED): the Role of Impulsivity, Compulsivity and Co-occurring Disorders

Laval University2 sites in 1 country200 target enrollmentMarch 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Binge-Eating Disorder
Sponsor
Laval University
Enrollment
200
Locations
2
Primary Endpoint
Binge Eating Scale score
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

  • Binge Eating Disorder (BED) has been fairly recently introduced into the Diagnostic and Statistical Manual 5 psychiatric classification and its severity criteria are still not well established.
  • Moreover, it remains unclear whether BED is associated with greater metabolic severity or more somatic comorbidities, especially in obesity.
  • Improved BED severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care.

The investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of BED (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated).

Registry
clinicaltrials.gov
Start Date
March 7, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sylvain Iceta

Principal Investigator

Laval University

Eligibility Criteria

Inclusion Criteria

  • men or women aged 1
  • participants eligible for bariatric surgery (BMI\>40, or BMI\>35 with severe comorbidities)
  • participants scheduled for medical evaluation and treatment of obesity at the IUCPQ Obesity Clinic (BMI≥30)
  • participants scheduled for evaluation and treatment of BED at the CEPIA with obesity (BMI≥30)
  • for the group with BED: positive BEDS-7 screen and Binge Eating Scale score \>16;
  • for the control group: have a negative BEDS-7 screen and Binge Eating Scale score\<12
  • be fluent in French and able to consent.
  • Exclusion criteria :
  • participants with severe neurological disorder and/or major neurocognitive deficits;
  • participants with previous bariatric surgery or with introduction or change of anti-obesity medication (liraglutide or naltrexone/bupropion) in the previous 3 months;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Binge Eating Scale score

Time Frame: Inclusion

To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982

Physical and psychological comorbidities

Time Frame: Inclusion

Number of current associated comorbidities to patient with and without BED

Secondary Outcomes

  • Glycated hemoglobin (HbA1C) in %(Inclusion)
  • Difficulties in emotion regulation scale short form, DERS(Inclusion)
  • Emotional Go / No-Go Task(Inclusion)
  • General Anxiety Disorder (GAD)-7(Inclusion)
  • Body Mass Index in kg.m-2(Inclusion)
  • Waist and hip circumferences in cm(Inclusion)
  • Visceral Adiposity Index(Inclusion)
  • Percentage of fat mass in %(Inclusion)
  • Fasting blood glucose in mmol/L(Inclusion)
  • Insulin in pmol/L(Inclusion)
  • Stop Signal Task(Inclusion)
  • Cholesterol HDL and LDL in mmol/L(Inclusion)
  • Obsessive-Compulsive Inventory-Revised, OCI-R(Inclusion)
  • Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS(Inclusion)
  • Integrated Visual and Auditory Continuous Performance Test, IVA-CPT(Inclusion)
  • Triglycerides in mmol/L(Inclusion)
  • UPPS-P Impulsive Behavior Scale short version, S-UPPS-P(Inclusion)
  • Patient Health Questionnaire (PHQ)-9(Inclusion)

Study Sites (2)

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