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

University Hospital Center (CHU) Dijon Bourgogne

Status: Terminated

Conditions: Diabetes; Obesity

Treatments: Other: Recording of GEP (Gustatory Evoked Potentials)

Study type: Interventional

Funder types: Other

Identifiers

NCT03228602

JACQUIN PEGASE 2016

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 4 patient groups

healthy subjects

Active Comparator group

Treatment:

Other: Recording of GEP (Gustatory Evoked Potentials)

obese

Experimental group

Treatment:

Other: Recording of GEP (Gustatory Evoked Potentials)

obese diabetic

Experimental group

Treatment:

Other: Recording of GEP (Gustatory Evoked Potentials)

obese diabetic who are going to be operated on

Experimental group

Description:

25 of a sleeve gastrectomy and 25 of a Y gastric bypass

Treatment:

Other: Recording of GEP (Gustatory Evoked Potentials)