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

Completed

• Conditions: Insulin Resistance

• Registration Number: NCT02941874
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Study Start: 2017-04-07
• Primary Completion: 2019-09-16
• Study Completion: 2019-12-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Institut de Biologie - Pathologie; 🇫🇷 Grenoble, Isere, France