ObesityPEGASENCT03228602
Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons
A study testing Recording of GEP (Gustatory Evoked Potentials) in people with Obesity and Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Recording of GEP (Gustatory Evoked Potentials)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2016to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects
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.
- Being tested
- Recording of GEP (Gustatory Evoked Potentials)
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Active comparator | Not described Receives: Other: Recording of GEP (Gustatory Evoked Potentials) |
| obese | Experimental | Not described Receives: Other: Recording of GEP (Gustatory Evoked Potentials) |
| obese diabetic | Experimental | Not described Receives: 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 Receives: Other: Recording of GEP (Gustatory Evoked Potentials) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the gustatory evoked potential
Measured: Up to 10 days
Latency of the gustatory evoked potential
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start11 Jul 2016
- Primary completion21 Jan 2021
- Study completion12 May 2021
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228602
- Sponsor's protocol ID
- JACQUIN PEGASE 2016
- Acronym
- PEGASE
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2017
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects
- ClinicalTrials.gov ID
- NCT03228602
- Acronym / sponsor ID
- PEGASE / JACQUIN PEGASE 2016
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Recording of GEP (Gustatory Evoked Potentials)25 of a sleeve gastrectomy and 25 of a Y gastric bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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"
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | healthy subjects, obese, obese diabetic, obese diabetic who are going to be operated on |
Primary outcome
Amplitude of the gustatory evoked potential
Time frame: Up to 10 days
Latency of the gustatory evoked potential
Time frame: Up to 10 days
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recording of GEP (Gustatory Evoked Potentials) in people with Obesity and Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of the gustatory evoked potential (time frame: Up to 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.