NCT03228602

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

4.5 years

First QC Date

June 26, 2017

Last Update Submit

June 8, 2022

Conditions

ObesityDiabetes

Outcome Measures

Primary Outcomes (2)

  • Amplitude of the gustatory evoked potential

    Up to 10 days

  • Latency of the gustatory evoked potential

    Up to 10 days

Study Arms (4)

healthy subjects

ACTIVE COMPARATOR
Other: Recording of GEP (Gustatory Evoked Potentials)

obese

EXPERIMENTAL
Other: Recording of GEP (Gustatory Evoked Potentials)

obese diabetic

EXPERIMENTAL
Other: Recording of GEP (Gustatory Evoked Potentials)

obese diabetic who are going to be operated on

EXPERIMENTAL

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

Other: Recording of GEP (Gustatory Evoked Potentials)

Interventions

Recording of GEP (Gustatory Evoked Potentials)OTHER

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.

healthy subjectsobeseobese diabeticobese diabetic who are going to be operated on

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 25, 2017

Study Start

July 11, 2016

Primary Completion

January 21, 2021

Study Completion

May 12, 2021

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations

FR(1)