Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04211818
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2019-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}], 'ancestors': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of episodes of bulimia (measured from the dietary book) according to the interstitial glucose levels', 'timeFrame': 'At the return of the dietary book (14 days after enrollment)', 'description': 'Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred'}], 'secondaryOutcomes': [{'measure': 'Levels of impulse to make a crisis and food obsession and hunger depending on interstitial glucose levels', 'timeFrame': 'At the return of the dietary book (14 days after enrollment)', 'description': 'Each information entered on the dietary book will be positioned on a chronological axis allowing to identify precisely when the eating disorder occurred'}, {'measure': 'Dietary patterns', 'timeFrame': 'At enrollment', '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bulimia', 'Binge Eating', 'Blood Glucose, Low', 'Crisis State', 'Compulsion']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This is an open-label, exploratory, proof-of-concept study.\n\n20 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.\n\nDuring 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.\n\nNo nutritional approach will be addressed so as not to alter the patient's eating behavior and not to influence the results.\n\nThey will be followed-up during 14 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject suffering from eating disorders with at least 3 episodes of bulimia per week for at least 2 months\n* Subject affiliated to a health insurance or beneficiary of such a plan\n* Subject able to understand the nature, purpose and methodology of the study\n* Subject signed informed consent\n\nExclusion Criteria:\n\n* Subject suffering from eating disorders such as anorexia nervosa\n* Subject unable according to the investigator's opinion to keep updated a dietary book or to perform correctly the glycemic recordings\n* 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\n* Major subject legally protected (guardians or curators) or deprived of freedom by judicial or administrative order\n* Pregnant or nursing woman"}, 'identificationModule': {'nctId': 'NCT04211818', 'acronym': 'GLUCOPULSE', 'briefTitle': 'Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach', 'orgStudyIdInfo': {'id': 'RECHMPL18_0470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'interventionNames': ['Behavioral: Eating Behavior', 'Biological: Blood glucose records']}], 'interventions': [{'name': 'Eating Behavior', 'type': 'BEHAVIORAL', 'description': 'A dietary book will be given to the patient and will be filled by this one during 14 days', 'armGroupLabels': ['Patients']}, {'name': 'Blood glucose records', 'type': 'BIOLOGICAL', 'description': "A glycemic sensor will be placed at the back of the patient's arm", 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34 295', 'city': 'Montpellier', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}