Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-09 @ 9:23 AM
Study NCT ID:
NCT03228602
Status:
TERMINATED
Last Update Posted:
2022-06-09
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'lack of inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of the gustatory evoked potential', 'timeFrame': 'Up to 10 days'}, {'measure': 'Latency of the gustatory evoked potential', 'timeFrame': 'Up to 10 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare several parameters in three distinct groups of subjects: persons with obesity, persons with obesity and diabetes and persons with neither obesity nor diabetes:\n\n* the electrical activity in response to a sweet solution, measured before and after a standard meal, using gustatory evoked potentials (recording explained below)\n* blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin: measured in blood samples)\n* levels of activity and quantity of an enzyme present in the saliva, amylase, which is able to break down ingested starch into several molecules of glucose.\n\nAll of these parameters will be correlated to determine whether the results are different in the 3 groups of subjects in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have provided written consent\n* Patients over 18 years old\n* Body Mass Index (BMI) \\<25 kg/m² for healthy volunteers and BMI≥30 kg/m² for obese subjects\n* Patients with type 2 diabetes for the group "obese diabetic subjects"\n\nExclusion Criteria:\n\n* Patients under guardianship\n* Patients without health insurance cover\n* Pregnant or breast-feeding women\n* Active smokers\n* Subjects with type 2 diabetes for the " healthy subjects " and " obese subjects ", subjects with type 1 diabetes for all groups\n* Subjects who do not speak French\n* Treatment that interferes with taste or acts on the central nervous system\n* Anti-diabetic treatment with GLP-1 analogues (Glucagon-like peptide 1) or SGLT2 (sodium-glucose cotransporter type 2)\n* Known hypersensitivity to the foods proposed in the study, or the paste used to fix the electrodes, or to paraffin wax or to the products tested (sucrose, glucose or starch for the gustatory evoked potentials and triangular tests)'}, 'identificationModule': {'nctId': 'NCT03228602', 'acronym': 'PEGASE', 'briefTitle': 'Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects', 'orgStudyIdInfo': {'id': 'JACQUIN PEGASE 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'healthy subjects', 'interventionNames': ['Other: Recording of GEP (Gustatory Evoked Potentials)']}, {'type': 'EXPERIMENTAL', 'label': 'obese', 'interventionNames': ['Other: Recording of GEP (Gustatory Evoked Potentials)']}, {'type': 'EXPERIMENTAL', 'label': 'obese diabetic', 'interventionNames': ['Other: Recording of GEP (Gustatory Evoked Potentials)']}, {'type': 'EXPERIMENTAL', 'label': 'obese diabetic who are going to be operated on', 'description': '25 of a sleeve gastrectomy and 25 of a Y gastric bypass', 'interventionNames': ['Other: Recording of GEP (Gustatory Evoked Potentials)']}], 'interventions': [{'name': 'Recording of GEP (Gustatory Evoked Potentials)', 'type': 'OTHER', 'description': 'record cerebral activity thanks to electrodes placed on the head and fixed with a painless, harmless adhesive paste and linked to a computer equipped with specific software to interpret the signals obtained. The collection of data for the electric signal takes 20 minutes.', 'armGroupLabels': ['healthy subjects', 'obese', 'obese diabetic', 'obese diabetic who are going to be operated on']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}