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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02941874
Acronym
IRAP
Enrollment
96
Registered
2016-10-21
Start date
2017-04-07
Completion date
2019-12-12
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

IRAP, Insulin Regulated Amino Peptidase, Diagnostic biomarker, Type 2 diabetes

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.

Interventions

OTHERBlood 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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 intakeThree 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

MeasureTime frameDescription
Repeatability of the IRAP measurementAt the beginning of the second visit of the study, before the glucose intakeThe 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 IRAPAt the beginning of the second visit of the study, before the glucose intakeThe 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

MeasureTime frameDescription
kinetic profile of the concentration of IRAP during OGTTDuring the 3 hours OGTT at the second visitEvolution of the serum concentration of IRAP during the 3 hours which follow the ingestion of 75g of glucose.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026