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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04211818
Other study ID # RECHMPL18_0470_2019-A00950-57
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2020
Est. completion date July 2023

Study information

Verified date May 2022
Source University Hospital, Montpellier
Contact Sébastien GUILLAUME
Phone +33(0)467338289
Email s-guillaume@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Eating Behavior
A dietary book will be given to the patient and will be filled by this one during 14 days
Biological:
Blood glucose records
A glycemic sensor will be placed at the back of the patient's arm

Locations

Country Name City State
France University Hospital Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred At the return of the dietary book (14 days after enrollment)
Secondary Levels of impulse to make a crisis and food obsession and hunger depending on interstitial glucose levels Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred At the return of the dietary book (14 days after enrollment)
Secondary Dietary patterns Measured by the Emotional Appetite Questionnaire (EMAQ), 1 represent a food intake much smaller than usual ; 9 represent a food intake more significant than usual ; 5 represent a food intake as usual At enrollment
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