Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)
GLUCOPULSE
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedStudy Start
First participant enrolled
October 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedSeptember 30, 2025
May 1, 2022
1.9 years
December 23, 2019
September 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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)
Dietary patterns
At enrollment
Study Arms (1)
Patients
EXPERIMENTALInterventions
A dietary book will be given to the patient and will be filled by this one during 14 days
A glycemic sensor will be placed at the back of the patient's arm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Montpellier, 34 295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2019
First Posted
December 26, 2019
Study Start
October 16, 2020
Primary Completion
August 25, 2022
Study Completion
July 1, 2023
Last Updated
September 30, 2025
Record last verified: 2022-05