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.
1 other identifier
interventional
81
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2014
CompletedFebruary 9, 2026
February 1, 2026
1.9 years
December 18, 2013
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma levels of biological markers of orosensorielle perception fatty acids
Change from baseline at 15 days
Secondary Outcomes (1)
Measure the detection threshold for linoleic acid
baselines
Study Arms (3)
Patients with type 2 diabetes
OTHERObese patients without diabetes
OTHERHealthy volunteers
OTHERInterventions
Eligibility Criteria
You may qualify if:
- persons who have provided written consent
- Healthy volunteers:
- Men \> 18 years
- \<BMI \< 25 kg.m-2
- Fasting triglyceridemia \< 1.50 g/l
- Fasting glycemia \< 1.10 g/l
- 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
- +4 more criteria
You may not qualify if:
- Persons not covered by the national health insurance
- Persons with eating disorders:
- Severe digestive disease (enteropathy with absorption disorders, inflammatory digestive disease)
- Pancreatic insufficiency
- History of pancreas surgery
- Type 1 diabetes
- Renal insufficiency
- Hepatic insufficiency
- Treatment with proton pump inhibitors, insulin, GLP-1 analogues, DPP-4 inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon
Dijon, 21079, France
Related Publications (2)
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.
PMID: 24522446RESULTBesnard 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.
PMID: 32676702DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2013
First Posted
January 7, 2014
Study Start
May 11, 2010
Primary Completion
March 30, 2012
Study Completion
March 30, 2012
Last Updated
February 9, 2026
Record last verified: 2026-02