Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein

Study Overview
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Brief Summary
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The purpose of this study is on one hand to verify the measurement conformity of the IRAP dosage and on the other hand to obtain normal values of the blood IRAP concentration on healthy volunteers.

Detailed Description
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This study consists of two visits, from two to five days apart. The first visit : Healthy volunteers will be on an empty stomach. they will have a clinical examination, blood tests and blood samples will be taken to constitute a blood collection. the IRAP concentration will be measured with those samples. The second visit : This visit will take place in an interval from 2 to 5 days after the first visit. Subjects will be on an empty stomach An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken three time 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes to measure insulinemia, blood glucose, and IRAP concentration.

Official Title
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Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Specific Marker of the Cellular Captation of Glucose: the IRAP Protein (Insulin Regulated AminoPeptidase)

Conditions
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Insulin Resistance

Intervention / Treatment
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* Other: Blood sample collection during an OGTT to assess IRAP blood concentration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 19 and 25 Kg/m² No intercurrent disease during the last week No chronic infectious disease No smoker, no alcoholic Exclusion Criteria: history of : thyroid disease, liver or renal disease, endocrine and metabolic disease, cardiovascular disease, lung disease, gastroenterological disorders, psychiatric disease, Epilepsy Consumption of narcotic drug Blood donation dating less than 2 months Pregnancy or breast-feeding, or intent to become pregnant during the study period legal exclusion criteria

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers IRAP measurement<br> | Other: Blood sample collection during an OGTT to assess IRAP blood concentration<br>* Blood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal values of IRAP concentration will be calculated by making the average of the three dosages of IRAP measured at base line. | Three blood samples will be taken 15 minutes apart, before the OGTT. The average of IRAP concentration measured with those 3 samples, will be used to assess the normal values of IRAP concentration on a healthy population. | At the beginning of the second visit of the study, before the glucose intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of the IRAP measurement | The repeatability will be assessed during the second visit. The measurement of IRAP concentration will be repeated 3 times on the first sample taken before the OGTT. | At the beginning of the second visit of the study, before the glucose intake | 
| Temporal reproducibility of the concentration of IRAP | The reproducibility will be assessed during the second visit. The measurement of IRAP concentration will be repeated 3 times on the first sample taken before the OGTT. | At the beginning of the second visit of the study, before the glucose intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IRAP, Insulin Regulated Amino Peptidase, Diagnostic biomarker, Type 2 diabetes