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Completed

NCT Number: NCT02028975

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.

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.

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Key information

Conditions

Type 2 Diabetes or Obesity Without Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon

Dijon, 21079, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

  • 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
  • Type 1 diabetes
  • Renal insufficiency
  • Hepatic insufficiency
  • Treatment with proton pump inhibitors, insulin, GLP-1 analogues, DPP-4 inhibitors

Treatment and study plan

Measure the threshold of detection for linoleic acid

Other

Oral stimulation tests

Other

venous blood samples

Other

Samples for genetic studies (ancillary study)

Other

Primary outcomes

  1. Plasma levels of biological markers of orosensorielle perception fatty acids

    Time frame: Change from baseline at 15 days

Secondary outcomes

  1. Measure the detection threshold for linoleic acid

    Time frame: baselines

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 7, 2014
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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