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.

January 6, 2014 updated by: Centre Hospitalier Universitaire Dijon

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with type 2 diabetes
Other: Measure the threshold of detection for linoleic acid
Other: Oral stimulation tests
Other: Venous blood samples
Other: Samples for genetic studies (ancillary study)
Other: Healthy volunteers
Other: Measure the threshold of detection for linoleic acid
Other: Oral stimulation tests
Other: Venous blood samples
Other: Samples for genetic studies (ancillary study)
Other: Obese patients without diabetes
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of biological markers of orosensorielle perception fatty acids
Time Frame: Change from baseline at 15 days
Change from baseline at 15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure the detection threshold for linoleic acid
Time Frame: baselines
baselines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VERGES 2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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