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

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ClinicalTrials.gov Identifier: NCT01948414
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Hyperalimentation and Obesity Procedure: electroencephalography Biological: Blood sampling Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction
Study Start Date : July 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
obese women with eating disorders
Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8
Procedure: electroencephalography
Biological: Blood sampling
Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
Obese women without eating desorders
Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8
Procedure: electroencephalography
Biological: Blood sampling
Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
Lean women
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
Procedure: electroencephalography
Biological: Blood sampling
Behavioral: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)



Primary Outcome Measures :
  1. P300 amplitude [ Time Frame: At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion ]
    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 :
  1. Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode) [ Time Frame: fasting (up to 15 days) ]
    The technique of auditory ERP will be an auditory discriminated task paradigm

  2. assessment of dietary restraints and disinhibition [ Time Frame: fasting (up to 15 days) ]
    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).

  3. glucose, insulin, leptin and ghrelin plasmatic rate [ Time Frame: fasting (up to 15 days) ]
    respectively reverse-phase high-performance liquid chromatography (RP-HPLC), ImmunoRadio Metric (IRMA) and ELISA assay

  4. dopamine D2 receptor Taq 1 polymorphism [ Time Frame: fasting (up to 15 days) ]
    Real time PCR

  5. Dietary intake and eating patterns [ Time Frame: At day 1 and at day 15 ]
    Women will be interviewed by dietician, using a 24 h food questionnaire with additional questions regarding health and eating habits



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948414


Locations
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France
CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé Centre Hospitalier Lyon Sud - Pavillon médical 165, chemin du Grand Revoyet
Pierre Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Emmanuel DISSE, Pratician CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé - Centre Hospitalier Lyon Sud

Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01948414     History of Changes
Other Study ID Numbers: 2012.784
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Keywords provided by Hospices Civils de Lyon:
Obesity
Hyperalimentation
Event-Related Potential
P300
Additional relevant MeSH terms:
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Hyperphagia
Feeding and Eating Disorders
Signs and Symptoms
Mental Disorders
Signs and Symptoms, Digestive