Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons

Not Applicable

Terminated

• Conditions: Obesity; Diabetes
• Interventions: Other: Recording of GEP (Gustatory Evoked Potentials)

• Registration Number: NCT03228602
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-07-11
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Primary Completion: 2021-01-21
• Study Completion: 2021-05-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy subjects	Recording of GEP (Gustatory Evoked Potentials)	-
obese diabetic	Recording of GEP (Gustatory Evoked Potentials)	-
obese diabetic who are going to be operated on	Recording of GEP (Gustatory Evoked Potentials)	25 of a sleeve gastrectomy and 25 of a Y gastric bypass
obese	Recording of GEP (Gustatory Evoked Potentials)	-

Primary Outcome Measures

Name	Time	Method
Amplitude of the gustatory evoked potential	Up to 10 days
Latency of the gustatory evoked potential	Up to 10 days

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France