search
Back to results

Cognitive Processes Study in Obese Women With and Without Eating Disorders (P300)

Primary Purpose

Hyperalimentation and Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalography
Blood sampling
Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperalimentation and Obesity focused on measuring Obesity, Hyperalimentation, Event-Related Potential, P300

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé Centre Hospitalier Lyon Sud - Pavillon médical 165, chemin du Grand Revoyet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

obese women with eating disorders

Obese women without eating desorders

Lean women

Arm Description

Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher 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

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

Outcomes

Primary Outcome Measures

P300 amplitude
The auditory event-related potentials measure will be elicited with an auditory oddball paradigm. The activity will be recorded thanks to electroencephalography from frontal, central and parietal electrodes, using an electrode cap.

Secondary Outcome Measures

Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)
The technique of auditory ERP will be an auditory discriminated task paradigm
assessment of dietary restraints and disinhibition
Participants will complete self-report questionnaires including Three-Factor Eating Questionnaire and Eating Disorders Inventory. The lean subjects should not have TFEQ disinhibition score more than 8. The obese subjects will be separated on two groups depending on TFEQ dishinibition score (strictly greater than 8, the obese with eating disorder, less than or equal 8, obese without eating disorder).
glucose, insulin, leptin and ghrelin plasmatic rate
respectively reverse-phase high-performance liquid chromatography (RP-HPLC), ImmunoRadio Metric (IRMA) and ELISA assay
dopamine D2 receptor Taq 1 polymorphism
Real time PCR
Dietary intake and eating patterns
Women will be interviewed by dietician, using a 24 h food questionnaire with additional questions regarding health and eating habits

Full Information

First Posted
September 2, 2013
Last Updated
August 26, 2016
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT01948414
Brief Title
Cognitive Processes Study in Obese Women With and Without Eating Disorders
Acronym
P300
Official Title
Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalimentation and Obesity
Keywords
Obesity, Hyperalimentation, Event-Related Potential, P300

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obese women with eating disorders
Arm Type
Other
Arm Description
Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8
Arm Title
Obese women without eating desorders
Arm Type
Other
Arm Description
Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8
Arm Title
Lean women
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
electroencephalography
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
Primary Outcome Measure Information:
Title
P300 amplitude
Description
The auditory event-related potentials measure will be elicited with an auditory oddball paradigm. The activity will be recorded thanks to electroencephalography from frontal, central and parietal electrodes, using an electrode cap.
Time Frame
At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion
Secondary Outcome Measure Information:
Title
Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)
Description
The technique of auditory ERP will be an auditory discriminated task paradigm
Time Frame
fasting (up to 15 days)
Title
assessment of dietary restraints and disinhibition
Description
Participants will complete self-report questionnaires including Three-Factor Eating Questionnaire and Eating Disorders Inventory. The lean subjects should not have TFEQ disinhibition score more than 8. The obese subjects will be separated on two groups depending on TFEQ dishinibition score (strictly greater than 8, the obese with eating disorder, less than or equal 8, obese without eating disorder).
Time Frame
fasting (up to 15 days)
Title
glucose, insulin, leptin and ghrelin plasmatic rate
Description
respectively reverse-phase high-performance liquid chromatography (RP-HPLC), ImmunoRadio Metric (IRMA) and ELISA assay
Time Frame
fasting (up to 15 days)
Title
dopamine D2 receptor Taq 1 polymorphism
Description
Real time PCR
Time Frame
fasting (up to 15 days)
Title
Dietary intake and eating patterns
Description
Women will be interviewed by dietician, using a 24 h food questionnaire with additional questions regarding health and eating habits
Time Frame
At day 1 and at day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel DISSE, Pratician
Organizational Affiliation
CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé Centre Hospitalier Lyon Sud - Pavillon médical 165, chemin du Grand Revoyet
City
Pierre Bénite
ZIP/Postal Code
69310
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.crnh-rhone-alpes.fr
Description
Related Info

Learn more about this trial

Cognitive Processes Study in Obese Women With and Without Eating Disorders

We'll reach out to this number within 24 hrs