Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons
NCT ID: NCT03228602
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
58 participants
INTERVENTIONAL
2016-07-11
2021-05-12
Brief Summary
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* the electrical activity in response to a sweet solution, measured before and after a standard meal, using gustatory evoked potentials (recording explained below)
* blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin: measured in blood samples)
* 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.
All of these parameters will be correlated to determine whether the results are different in the 3 groups of subjects in the study.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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healthy subjects
Recording of GEP (Gustatory Evoked Potentials)
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.
obese
Recording of GEP (Gustatory Evoked Potentials)
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.
obese diabetic
Recording of GEP (Gustatory Evoked Potentials)
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.
obese diabetic who are going to be operated on
25 of a sleeve gastrectomy and 25 of a Y gastric bypass
Recording of GEP (Gustatory Evoked Potentials)
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.
Interventions
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Recording of GEP (Gustatory Evoked Potentials)
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.
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years old
* Body Mass Index (BMI) \<25 kg/m² for healthy volunteers and BMI≥30 kg/m² for obese subjects
* Patients with type 2 diabetes for the group "obese diabetic subjects"
Exclusion Criteria
* Patients without health insurance cover
* Pregnant or breast-feeding women
* Active smokers
* Subjects with type 2 diabetes for the " healthy subjects " and " obese subjects ", subjects with type 1 diabetes for all groups
* Subjects who do not speak French
* Treatment that interferes with taste or acts on the central nervous system
* Anti-diabetic treatment with GLP-1 analogues (Glucagon-like peptide 1) or SGLT2 (sodium-glucose cotransporter type 2)
* 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)
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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JACQUIN PEGASE 2016
Identifier Type: -
Identifier Source: org_study_id
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