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Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03228602
Acronym
PEGASE
Enrollment
58
Registered
2017-07-25
Start date
2016-07-11
Completion date
2021-05-12
Last updated
2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Obesity

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.

Interventions

OTHERRecording 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.

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Amplitude of the gustatory evoked potentialUp to 10 days
Latency of the gustatory evoked potentialUp to 10 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026