Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons

NCT ID: NCT03228602

Last Updated: 2022-06-09

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2021-05-12

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Obesity Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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healthy subjects

Group Type ACTIVE_COMPARATOR

Recording of GEP (Gustatory Evoked Potentials)

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Recording of GEP (Gustatory Evoked Potentials)

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Recording of GEP (Gustatory Evoked Potentials)

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Recording of GEP (Gustatory Evoked Potentials)

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have provided written consent
* 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 under guardianship
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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JACQUIN PEGASE 2016

Identifier Type: -

Identifier Source: org_study_id

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