Clinical trial NCT04211818: Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)
Official title: Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bulimia
Binge Eating
Blood Glucose, Low
Crisis State
Compulsion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels
timeFrame: At the return of the dietary book (14 days after enrollment)
Secondary outcomes:
measure: Levels of impulse to make a crisis and food obsession and hunger depending on interstitial glucose levels
timeFrame: At the return of the dietary book (14 days after enrollment)
measure: Dietary patterns
timeFrame: At enrollment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
References: