CompletedNot Applicable

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.

France81 participantsStarted 2010-05-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma levels of biological markers of orosensorielle perception fatty acids

Timeframe: Change from baseline at 15 days

Trial details

NCT IDNCT02028975

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03-30

View on ClinicalTrials.gov More Type 2 Diabetes or Obesity Without Diabetes trials