Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons (PEGASE)

Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Other: Recording of GEP (Gustatory Evoked Potentials)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy subjects	Other: 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.
Experimental: obese	Other: 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.
Experimental: obese diabetic	Other: 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.
Experimental: obese diabetic who are going to be operated on; 25 of a sleeve gastrectomy and 25 of a Y gastric bypass	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amplitude of the gustatory evoked potential	Up to 10 days
Latency of the gustatory evoked potential	Up to 10 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2016
• Primary Completion (Actual): January 21, 2021
• Study Completion (Actual): May 12, 2021

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: JACQUIN PEGASE 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No