Back to resultsAnalysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE) (GLUCOPULSE)
Primary Purpose
Bulimia, Binge Eating, Blood Glucose, Low
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eating Behavior
Blood glucose records
Sponsored by
About this trial
This is an interventional other trial for Bulimia
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
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04211818
First Posted
December 23, 2019
Last Updated
May 16, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT04211818
Brief Title
Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)
Acronym
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia, Binge Eating, Blood Glucose, Low, Crisis State, Compulsion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Eating Behavior
Intervention Description
A dietary book will be given to the patient and will be filled by this one during 14 days
Intervention Type
Biological
Intervention Name(s)
Blood glucose records
Intervention Description
A glycemic sensor will be placed at the back of the patient's arm
Primary Outcome Measure Information:
Title
Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels
Description
Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred
Time Frame
At the return of the dietary book (14 days after enrollment)
Secondary Outcome Measure Information:
Title
Levels of impulse to make a crisis and food obsession and hunger depending on interstitial glucose levels
Description
Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred
Time Frame
At the return of the dietary book (14 days after enrollment)
Title
Dietary patterns
Description
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
Time Frame
At enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien GUILLAUME
Phone
+33(0)467338289
Email
s-guillaume@chu-montpellier.fr
Facility Information:
Facility Name
University Hospital
City
Montpellier
ZIP/Postal Code
34 295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain THIEBAUT
12. IPD Sharing Statement
Learn more about this trial
Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)
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