Clinical trial NCT02941874: Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Keywords: IRAP
Insulin Regulated Amino Peptidase
Diagnostic biomarker
Type 2 diabetes
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects distributed according to 3 age groups (40-49 years old , 50-59 years old, 60-70 years old). Every age bracket will be balanced in sex.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Normal values of IRAP concentration will be calculated by making the average of the three dosages of IRAP measured at base line.
timeFrame: At the beginning of the second visit of the study, before the glucose intake
Secondary outcomes:
measure: Repeatability of the IRAP measurement
timeFrame: At the beginning of the second visit of the study, before the glucose intake
measure: Temporal reproducibility of the concentration of IRAP
timeFrame: At the beginning of the second visit of the study, before the glucose intake
Other outcomes:
measure: kinetic profile of the concentration of IRAP during OGTT
timeFrame: During the 3 hours OGTT at the second visit
Locations:
city: Grenoble
country: France
facility: Institut de Biologie - Pathologie
state: Isere
Study officials:
References: