跳至主要内容
临床试验/NCT04211818
NCT04211818已完成不适用

Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年10月16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
20
试验地点
1
主要终点
Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels

研究概览

简要总结

Eating Disorders (ED) are a major public health problem. Current care remains only partially effective and the pathophysiology of the disorders remains to be deepened. With regard to compulsive ED (bulimia and binge eating disorder), our clinical experience suggests that one of the major triggers for crisis may be related to glycemia. In fact, bulimia could be considered as a vicious circle where the binge eating disorder is going to be followed by a food restriction in order to control weight , putting the subject in a situation of "energy deficiency" which will favor the emergence of new crises . Technological advances have resulted in the emergence of new measuring devices, such as "tracking", which records continuous glycemia, which would allow us to explore these clinical hypotheses.

详细描述

This is an open-label, exploratory, proof-of-concept study.

20 patients will be recruited from the day hospital of the Endocrinology and Nutrition Department of the University Hospital of Montpellier, Lapeyronie and from Emergencies and Post-psychiatric Emergencies Department.

During the inclusion visit, the dietician will explain to the patient the use of the dietary book and the glycemic sensor which will be allocated to it. The patient will also answer to self-questionnaires about his eating behavior.

No nutritional approach will be addressed so as not to alter the patient's eating behavior and not to influence the results.

They will be followed-up during 14 days.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject suffering from eating disorders with at least 3 episodes of bulimia per week for at least 2 months
  • Subject affiliated to a health insurance or beneficiary of such a plan
  • Subject able to understand the nature, purpose and methodology of the study
  • Subject signed informed consent

排除标准

  • Subject suffering from eating disorders such as anorexia nervosa
  • Subject unable according to the investigator's opinion to keep updated a dietary book or to perform correctly the glycemic recordings
  • Subject suffering from somatic pathology (ex: diabetes) or psychiatric pathology assessed by the MINI (ex : severe current major depressive episode) that may interfere with the protocol according to the the investigator
  • Major subject legally protected (guardians or curators) or deprived of freedom by judicial or administrative order
  • Pregnant or nursing woman

研究组 & 干预措施

Patients

Experimental

干预措施: Blood glucose records (Biological)

Patients

Experimental

干预措施: Eating Behavior (Behavioral)

结局指标

主要结局

Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels

时间窗: At the return of the dietary book (14 days after enrollment)

Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred

次要结局

  • Dietary patterns(At enrollment)
  • Levels of impulse to make a crisis and food obsession and hunger depending on interstitial glucose levels(At the return of the dietary book (14 days after enrollment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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