BulimiaGLUCOPULSENCT04211818
Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)
A study testing Eating Behavior and Blood glucose records in people with Bulimia and Binge Eating, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bulimia, Binge Eating, Blood Glucose, Low
- What is being tested?
- Eating Behavior and Blood glucose records
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2020to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bulimia, Binge Eating, Blood Glucose, Low, Crisis State, Compulsion
- Being tested
- Eating Behavior, Blood glucose records
- Medical subject headings
- Bulimia, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating BehaviorBehavioural
A dietary book will be given to the patient and will be filled by this one during 14 days
Blood glucose recordsBiological
A glycemic sensor will be placed at the back of the patient's arm
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Behavioral: Eating Behavior; Biological: Blood glucose records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred
Measured: 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
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start16 Oct 2020
- Primary completion25 Aug 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BulimiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211818
- Sponsor's protocol ID
- RECHMPL18_0470
- Acronym
- GLUCOPULSE
- Status last verified
- May 2022
- First submitted
- 23 Dec 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach
- ClinicalTrials.gov ID
- NCT04211818
- Acronym / sponsor ID
- GLUCOPULSE / RECHMPL18_0470
- Conditions
- Bulimia, Binge Eating, Blood Glucose, Low, Crisis State, Compulsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Behavioral: Eating Behavior, Biological: Blood glucose records |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating BehaviorA dietary book will be given to the patient and will be filled by this one during 14 days | Behavioural | Patients |
| Blood glucose recordsA glycemic sensor will be placed at the back of the patient's arm | Biological | Patients |
Primary outcome
Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels
Time frame: 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 secondary outcomes
Levels of impulse to make a crisis and food obsession and hunger depending on interstitial glucose levels
Time frame: At the return of the dietary book (14 days after enrollment)
Dietary patterns
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating Behavior and Blood glucose records in people with Bulimia and Binge Eating, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels (time frame: At the return of the dietary book (14 days after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.