Type 2 Diabetes or Obesity Without DiabetesNCT02028975
Search for Biological Markers of Orosensory Perception of Fatty Acids in Healthy Subjects and Possible Modifications in Patients With Type 2 Diabetes and in Obese Non-diabetic Patients.
A study testing Measure the threshold of detection for linoleic acid, Oral stimulation tests and Venous blood samples in people with Type 2 Diabetes or Obesity Without Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to determine in healthy humans whether the orosensory perception of fatty acids is followed by a modification in plasma levels of digestive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes or Obesity Without Diabetes
- What is being tested?
- Measure the threshold of detection for linoleic acid, Oral stimulation tests and Venous blood samples
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2010to 30 Mar 2012
- 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
- Adult, Older adult
Who may be able to join
- persons who have provided written consent
- Healthy volunteers:
- Men > 18 years
- 19 <BMI < 25 kg.m-2
- Fasting triglyceridemia < 1.50 g/l
- Fasting glycemia < 1.10 g/l
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- Without regular medical treatment
- Patients with type-2 diabetes:
- Men >18 years
- type 2 diabetes (fasting glycemia > 7 mmol/l at the diagnosis) treated with diet or diet + oral antidiabetics (metformin, and/or insulinsecretion agents [hypoglycemic sulphonamides, or glinides] and/or glitazones and/or acarbose)
- Stable oral antidiabetic treatment for 3 months
- Obese non-diabetic patients:
- Men > 18 years
- BMI 30 kg.m-2
- Fasting glycemia < 1.10 g/l
- HbA1c < 6.0%
- Absence of treatment with hypoglycemic agents (including benfluorex)
- Absence of medical treatment for obesity
- Absence of a history of surgery for obesity (band, by-pass) or gastric stimulator (type Tantalus)
Who cannot join
- Persons not covered by the national health insurance
- Smokers, or smoking cessation within the 3 months preceding inclusion
- Persons with eating disorders:
- Severe digestive disease (enteropathy with absorption disorders, inflammatory digestive disease)
- Pancreatic insufficiency
- History of pancreas surgery
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- Type 1 diabetes
- Renal insufficiency
- Hepatic insufficiency
- Treatment with proton pump inhibitors, insulin, GLP-1 analogues, DPP-4 inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to determine in healthy humans whether the orosensory perception of fatty acids is followed by a modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1, secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue (leptin, ghrelin, adiponectin).
We also aim to determine whether the hormonal response induced by orosensory stimulation by lipids is modified:
Read more
- in patients with type 2 diabetes
- in obese non-diabetic patients We expect to show an increase in biological markers biological, and more particularly in certain digestive hormones such as Pancreatic polypeptide, GIP, GLP-1…after stimulation of the lingual lipid receptor, CD36. We will also determine whether or not this response is modified in patients with type 2 diabetes and in obese non-diabetic patients.
We also wish to measure the subjects' gustatory detection threshold for a fatty acid (linoleic acid), and to determine whether there is a relationship between the orosensory perception threshold for linoleic acid and the physiological status of the subjects. In order to achieve this, the thresholds for healthy subjects will be compared with thresholds for obese and diabetic subjects. Expected results: the threshold of detection for linoleic acid in healthy subjects will be lower than that in obese or diabetic patients.
- Being tested
- Measure the threshold of detection for linoleic acid, Oral stimulation tests, Venous blood samples, Samples for genetic studies (ancillary study)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure the threshold of detection for linoleic acidOther
Oral stimulation testsOther
Venous blood samplesOther
Samples for genetic studies (ancillary study)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Other | Not described Receives: Other: Measure the threshold of detection for linoleic acid; Other: Oral stimulation tests; Other: Venous blood samples; Other: Samples for genetic studies (ancillary study) |
| Obese patients without diabetes | Other | Not described Receives: Other: Measure the threshold of detection for linoleic acid; Other: Oral stimulation tests; Other: Venous blood samples; Other: Samples for genetic studies (ancillary study) |
| Healthy volunteers | Other | Not described Receives: Other: Measure the threshold of detection for linoleic acid; Other: Oral stimulation tests; Other: Venous blood samples; Other: Samples for genetic studies (ancillary study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of biological markers of orosensorielle perception fatty acids
Measured: Change from baseline at 15 days
Secondary outcomes (1)
Measure the detection threshold for linoleic acid
Measured: baselines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study start11 May 2010
- Primary completion30 Mar 2012
- Study completion30 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes or Obesity Without DiabetesStudies 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
- Enrolment
- 81 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
- NCT02028975
- Sponsor's protocol ID
- VERGES 2009
- Status last verified
- Feb 2026
- First submitted
- 18 Dec 2013
- Last updated
- 9 Feb 2026
- Results posted
- No
Publications
Chevrot M, Passilly-Degrace P, Ancel D, Bernard A, Enderli G, Gomes M, Robin I, Issanchou S, Verges B, Nicklaus S, Besnard P. Obesity interferes with the orosensory detection of long-chain fatty acids in humans. Am J Clin Nutr. 2014 May;99(5):975-83. doi: 10.3945/ajcn.113.077198. Epub 2014 Feb 12.
PubMed 24522446Besnard P, Christensen JE, Bernard A, Simoneau-Robin I, Collet X, Verges B, Burcelin R. Identification of an oral microbiota signature associated with an impaired orosensory perception of lipids in insulin-resistant patients. Acta Diabetol. 2020 Dec;57(12):1445-1451. doi: 10.1007/s00592-020-01567-9. Epub 2020 Jul 16.
PubMed 32676702
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for Biological Markers of Orosensory Perception of Fatty Acids in Healthy Subjects and Possible Modifications in Patients With Type 2 Diabetes and in Obese Non-diabetic Patients.
- ClinicalTrials.gov ID
- NCT02028975
- Acronym / sponsor ID
- VERGES 2009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 11 May 2010 (actual)
- Primary completion
- 30 Mar 2012 (actual)
- Study completion
- 30 Mar 2012 (actual)
- First posted
- 7 Jan 2014 (estimated)
- 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.
Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to determine in healthy humans whether the orosensory perception of fatty acids is followed by a modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1, secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue (leptin, ghrelin, adiponectin).
We also aim to determine whether the hormonal response induced by orosensory stimulation by lipids is modified:
- in patients with type 2 diabetes
- in obese non-diabetic patients We expect to show an increase in biological markers biological, and more particularly in certain digestive hormones such as Pancreatic polypeptide, GIP, GLP-1…after stimulation of the lingual lipid receptor, CD36. We will also determine whether or not this response is modified in patients with type 2 diabetes and in obese non-diabetic patients.
We also wish to measure the subjects' gustatory detection threshold for a fatty acid (linoleic acid), and to determine whether there is a relationship between the orosensory perception threshold for linoleic acid and the physiological status of the subjects. In order to achieve this, the thresholds for healthy subjects will be compared with thresholds for obese and diabetic subjects. Expected results: the threshold of detection for linoleic acid in healthy subjects will be lower than that in obese or diabetic patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | Other | Other: Measure the threshold of detection for linoleic acid, Other: Oral stimulation tests, Other: Venous blood samples, Other: Samples for genetic studies (ancillary study) |
| Obese patients without diabetes | Other | Other: Measure the threshold of detection for linoleic acid, Other: Oral stimulation tests, Other: Venous blood samples, Other: Samples for genetic studies (ancillary study) |
| Healthy volunteers | Other | Other: Measure the threshold of detection for linoleic acid, Other: Oral stimulation tests, Other: Venous blood samples, Other: Samples for genetic studies (ancillary study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- persons who have provided written consent
- Healthy volunteers:
- Men > 18 years
- 19 <BMI < 25 kg.m-2
- Fasting triglyceridemia < 1.50 g/l
Key exclusion criteria (10 listed)
- Persons not covered by the national health insurance
- Smokers, or smoking cessation within the 3 months preceding inclusion
- Persons with eating disorders:
- Severe digestive disease (enteropathy with absorption disorders, inflammatory digestive disease)
- Pancreatic insufficiency
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 |
|---|---|---|
| Measure the threshold of detection for linoleic acid | Other | Healthy volunteers, Obese patients without diabetes, Patients with type 2 diabetes |
| Oral stimulation tests | Other | Healthy volunteers, Obese patients without diabetes, Patients with type 2 diabetes |
| Venous blood samples | Other | Healthy volunteers, Obese patients without diabetes, Patients with type 2 diabetes |
| Samples for genetic studies (ancillary study) | Other | Healthy volunteers, Obese patients without diabetes, Patients with type 2 diabetes |
Primary outcome
Plasma levels of biological markers of orosensorielle perception fatty acids
Time frame: Change from baseline at 15 days
1 secondary outcome
Measure the detection threshold for linoleic acid
Time frame: baselines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 24522446Chevrot M, Passilly-Degrace P, Ancel D, Bernard A, Enderli G, Gomes M, Robin I, Issanchou S, Verges B, Nicklaus S, Besnard P. Obesity interferes with the orosensory detection of long-chain fatty acids in humans. Am J Clin Nutr. 2014 May;99(5):975-83. doi: 10.3945/ajcn.113.077198. Epub 2014 Feb 12.
- Derived from this study: PubMed 32676702Besnard P, Christensen JE, Bernard A, Simoneau-Robin I, Collet X, Verges B, Burcelin R. Identification of an oral microbiota signature associated with an impaired orosensory perception of lipids in insulin-resistant patients. Acta Diabetol. 2020 Dec;57(12):1445-1451. doi: 10.1007/s00592-020-01567-9. Epub 2020 Jul 16.
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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 Measure the threshold of detection for linoleic acid, Oral stimulation tests and Venous blood samples in people with Type 2 Diabetes or Obesity Without 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 19 inclusion and 10 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: finished, as of the sponsor's last update on 9 Feb 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma levels of biological markers of orosensorielle perception fatty acids (time frame: Change from baseline at 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02028975, which also lists 2 linked publications.
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 Feb 2026.