NCT04028895

Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance

Assessement of the Diagnostic Interest in Insulin Resistance of the Specific and Quantitative ELISA Assay of a Plasma Biomarker of Cellular Glucose Capture: the Secreted IRAP Protein (Regulated Amino Peptidase Insulin)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

There is currently no reliable, diagnostic tests of insulin resistance other than the hyperinsulinemic euglycemic clamp which, due to its constraints and cost, is reserved for research. The insulin-Regulated aminopeptidase (IRAP) protein is a direct marker of insulin-dependent glucose cell capture and thus it blood concentration seems to be a good diagnostic test of insulin resistance. The purpose of this study is to assess a plasma essay of IRAP protein for evaluation of insulin resistance during an oral glucose tolerance test (OGTT).

Detailed description

This study consists of two visits, from three to fifteen days apart. Patients with different levels of insulin resistance will be enrolled in this study. The level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp that will be performed at the second visit. The first visit : * Subjects will be on an empty stomach * A blood test including HbA1C, C-Peptid, lipid profile, creatinine,urea, hepatic workup * An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken two time (T-15', T0) 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes (T15', T30', T 45', T60', T75', T90', T105', T120' and 180') to measure insulinemia, blood sugar, and IRAP concentration. The second visit includes a 3-hours hyperinsulinemic euglycemic clamp.

Conditions

• Insulin Resistance Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dosage of IRAP during OGTT	Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp

Timeline

• Start date: 2020-09-14
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-07-23
• Last updated: 2022-08-11

Locations

4 sites across 1 country: France