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

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)

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Other: Blood sample collection during an OGTT to assess IRAP blood concentration

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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• France
  • Isere
    • Grenoble, Isere, France, 38043
      • Institut de Biologie - Pathologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers IRAP measurement	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
kinetic profile of the concentration of IRAP during OGTT	Evolution of the serum concentration of IRAP during the 3 hours which follow the ingestion of 75g of glucose.	During the 3 hours OGTT at the second visit

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 7, 2017
• Primary Completion (ACTUAL): September 16, 2019
• Study Completion (ACTUAL): December 12, 2019

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (ESTIMATE): October 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 diabetes; IRAP; Insulin Regulated Amino Peptidase; Diagnostic biomarker
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 38RC16.131