Clinical trial NCT01948414: Cognitive Processes Study in Obese Women With and Without Eating Disorders
Official title: Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperalimentation and Obesity
Keywords: Obesity
Hyperalimentation
Event-Related Potential
P300
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to investigate the cognitive process. The P300 component are accepted as electro-physiological markers of neuropsychiatric disorders like alcoholism or drug addiction.

Recent scientific data suggest that eating disorders, leading to weight gain and obesity, will be similar of those of drug addiction: it is the incentive sensitization theory that implicates the dopaminergic reward system.

The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP in obese women with eating disorders in comparison with obese and lean women without eating disorders.


Eligibility criteria: Inclusion Criteria:

* women
* Aged from 20 to 55 years
* Fasting glycemia under 7mmol/L
* Lean women : women with BMI from 18.5 to 24.5 and disinhibition score to Three-Factor Eating Questionnaire (TFEQ)lower or equal to 8
* Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8
* Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8

Exclusion Criteria:

* Subject not in compliance with the recommendations of French National Law in force
* Medical history of diabetes and surgery history of obesity
* Drug use that could affect the ERP recording
* Hospital Anxiety and Depression scale : evaluation subscale (anxiety and/or depression) strictly higher to 11

Primary outcomes:
measure: P300 amplitude
timeFrame: At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion
Secondary outcomes:
measure: Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)
timeFrame: fasting (up to 15 days)
measure: assessment of dietary restraints and disinhibition
timeFrame: fasting (up to 15 days)
measure: glucose, insulin, leptin and ghrelin plasmatic rate
timeFrame: fasting (up to 15 days)
measure: dopamine D2 receptor Taq 1 polymorphism
timeFrame: fasting (up to 15 days)
measure: Dietary intake and eating patterns
timeFrame: At day 1 and at day 15
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé Centre Hospitalier Lyon Sud - Pavillon médical 165, chemin du Grand Revoyet
Study officials:
affiliation: CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud
name: Emmanuel DISSE, Pratician
role: PRINCIPAL_INVESTIGATOR
References: