Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons

Obesity Clinical Trial

— PEGASE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03228602
• Other study ID #: JACQUIN PEGASE 2016
• Status: Terminated
• Phase: N/A
• Start date: July 11, 2016
• Est. completion date: May 12, 2021

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: May 12, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

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.

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of the gustatory evoked potential		Up to 10 days
Primary	Latency of the gustatory evoked potential		Up to 10 days