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

Binge Eating Clinical Trial

— GLUCOPULSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211818
• Other study ID #: RECHMPL18_0470_2019-A00950-57
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Binge Eating
• Blood Glucose, Low
• Bulimia
• Compulsion
• Crisis State
• Feeding and Eating Disorders
• Food Addiction
• Hypoglycemia

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