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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bulimia; Binge Eating; Blood Glucose, Low; Compulsion; Crisis State
• Intervention / Treatment: Behavioral: Eating Behavior; Biological: Blood glucose records

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien GUILLAUME; Phone Number: +33(0)467338289; Email: s-guillaume@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34 295
    • Recruiting
    • University Hospital
    • Principal Investigator: Sylvain THIEBAUT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Anticipated): January 15, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Bulimia; Feeding and Eating Disorders; Food Addiction
• Other Study ID Numbers: RECHMPL18_0470_2019-A00950-57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No