Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This study consists of two visits, from two to five days apart.
The first visit :
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Healthy volunteers will be on an empty stomach.
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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.
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Subjects will be on an empty stomach
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy volunteers IRAP measurement
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Other: Blood sample collection during an OGTT to assess IRAP blood concentration
Blood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours
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Outcome Measures
Primary Outcome Measures
- Normal values of IRAP concentration will be calculated by making the average of the three dosages of IRAP measured at base line. [At the beginning of the second visit of the study, before the glucose intake]
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.
Secondary Outcome Measures
- Repeatability of the IRAP measurement [At the beginning of the second visit of the study, before the glucose intake]
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.
- Temporal reproducibility of the concentration of IRAP [At the beginning of the second visit of the study, before the glucose intake]
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.
Other Outcome Measures
- kinetic profile of the concentration of IRAP during OGTT [During the 3 hours OGTT at the second visit]
Evolution of the serum concentration of IRAP during the 3 hours which follow the ingestion of 75g of glucose.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Body mass index between 19 and 25 Kg/m²
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No intercurrent disease during the last week
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No chronic infectious disease
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No smoker, no alcoholic
Exclusion Criteria:
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history of : thyroid disease, liver or renal disease, endocrine and metabolic disease, cardiovascular disease, lung disease, gastroenterological disorders, psychiatric disease, Epilepsy
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Consumption of narcotic drug
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Blood donation dating less than 2 months
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Pregnancy or breast-feeding, or intent to become pregnant during the study period
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legal exclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Biologie - Pathologie | Grenoble | Isere | France | 38043 |
Sponsors and Collaborators
- University Hospital, Grenoble
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 38RC16.131