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

Insulin Resistance Clinical Trial

— IRAP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941874
• Other study ID #: 38RC16.131
• Status: Completed
• Start date: April 7, 2017
• Est. completion date: December 12, 2019

Study information

• Verified date: November 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 12, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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

Locations

Country	Name	City	State
France	Institut de Biologie - Pathologie	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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