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

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)

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).

Study Overview

• Status: Terminated
• Conditions: Insulin Resistance Syndrome
• Intervention / Treatment: Diagnostic test: Dosage of IRAP during 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Service de Nutrition clinique et CRNH Auvergne
  • Grenoble, France, 38043
    • Inserm CIC1406, clinical research center, Grenoble Alpes university hospital
  • Lyon, France, 69000
    • CRNH Rhône-Alpes et Centre Hospitalier LYON Sud
  • Montpellier, France
    • Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient without known diabetes
• Abdominal perimeter greater than 80 cm for women and greater than 94 cm for men
• Patient affiliated to social security insurance or beneficiary of social security insurance.
• Signed consent

Exclusion Criteria:

• Consumption of narcotic
• Medication that may interfere with glucose metabolism
• History of bariatric surgery
• Known acute or chronic renal insufficiency
• Hyperinsulinemic euglycemic clamp contraindication
• Contraindications with insulin, G20 glucose and Di-potassium phosphate
• Histories of coronary pathology
• History of heart rhythm disorders requiring chronic treatment
• Period of fast
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Experimental	Diagnostic test: Dosage of IRAP during OGTT; Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IRAP concentration during OGTT.	The level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp. The specificity and sensitivity of the IRAP concentration for the diagnosis of insulin resistance will be determined at every time of the OGTT.	At the first visit (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetic profile of IRAP concentration in 3-hours OGTT	Evolution of the concentration of IRAP at each point of the OGTT.	At the first visit (Day 0)
Diagnostic value of IRAP	Comparison of AUC (area under curve) of IRAP's ROC curves with that of insulin.	At the first visit (Day 0)
Diagnostic value of IRAP	Comparison of AUC (area under curve) of IRAP's ROC curves with that of glucose.	At the first visit (Day 0)
Diagnostic value of IRAP	Comparison of AUC (area under curve) of IRAP's ROC curves with that of resistance indexes.	At the first visit (Day 0)
Diagnostic value of the concentration of other biomarkers (not yet determined)	The diagnostic value of other potential insulin resistance biomarkers will be tested using the same methodology as for IRAP.	During the first visit (Day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2020
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: IRAP; Insulin Regulated Amino Peptidase
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: 38RC18.326

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No