Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT04028895
Status:
TERMINATED
Last Update Posted:
2022-08-11
First Post:
2019-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
stopped by the sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRAP-IR
Brief 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).
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: