NCT04211818

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

September 30, 2025

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

December 23, 2019

Last Update Submit

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

EXPERIMENTAL
Behavioral: Eating BehaviorBiological: Blood glucose records

Interventions

Eating BehaviorBEHAVIORAL

A dietary book will be given to the patient and will be filled by this one during 14 days

Patients

A glycemic sensor will be placed at the back of the patient's arm

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

BulimiaCompulsive Behavior

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsImpulsive BehaviorBehavior

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

Locations