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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04211818
Collaborator
(none)
20
1
1
32.5
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Eating Behavior
  • Biological: Blood glucose records
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach
Actual Study Start Date :
Oct 16, 2020
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels [At the return of the dietary book (14 days after enrollment)]

    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

  1. 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)]

    Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred

  2. Dietary patterns [At enrollment]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Montpellier France 34 295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04211818
Other Study ID Numbers:
  • RECHMPL18_0470_2019-A00950-57
First Posted:
Dec 26, 2019
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022