Hyperalimentation and Obesity Clinical Trial
— P300Official title:
Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction
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.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 55 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At the beginning of the exploration visit (when patient is fasting) that will take place between 1 and 15 days after inclusion | No |
| Secondary | 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 | fasting (up to 15 days) | No |
| Secondary | 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). | fasting (up to 15 days) | No |
| Secondary | glucose, insulin, leptin and ghrelin plasmatic rate | respectively reverse-phase high-performance liquid chromatography (RP-HPLC), ImmunoRadio Metric (IRMA) and ELISA assay | fasting (up to 15 days) | No |
| Secondary | dopamine D2 receptor Taq 1 polymorphism | Real time PCR | fasting (up to 15 days) | No |
| Secondary | 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 | At day 1 and at day 15 | No |