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临床试验/NCT01948414
NCT01948414已完成不适用

Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
P300 amplitude

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Lean women

Other

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

干预措施: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) (Behavioral)

obese women with eating disorders

Other

Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8

干预措施: electroencephalography (Procedure)

obese women with eating disorders

Other

Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8

干预措施: Blood sampling (Biological)

obese women with eating disorders

Other

Obese women with eating disorders : women with BMI higher or equal 35 and disinhibition score to TFEQ strictly higher to 8

干预措施: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) (Behavioral)

Obese women without eating desorders

Other

Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8

干预措施: electroencephalography (Procedure)

Obese women without eating desorders

Other

Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8

干预措施: Blood sampling (Biological)

Obese women without eating desorders

Other

Obese women without eating disorders : women with BMI higher or equal to 35 and disinhibition score to TFEQ lower or equal to 8

干预措施: Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD) (Behavioral)

Lean women

Other

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

干预措施: electroencephalography (Procedure)

Lean women

Other

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

干预措施: Blood sampling (Biological)

结局指标

主要结局

P300 amplitude

时间窗: 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.

次要结局

  • assessment of dietary restraints and disinhibition(fasting (up to 15 days))
  • Dietary intake and eating patterns(At day 1 and at day 15)
  • glucose, insulin, leptin and ghrelin plasmatic rate(fasting (up to 15 days))
  • Auditory ERP ( latency P300, amplitude and latency of N2 wave recorded from frontal, central and parietal electrode)(fasting (up to 15 days))
  • dopamine D2 receptor Taq 1 polymorphism(fasting (up to 15 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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