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)

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

Sponsors

Lead sponsor: University Hospital, Grenoble

Source University Hospital, Grenoble
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).

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.

Overall Status Not yet recruiting
Start Date February 28, 2020
Completion Date February 28, 2022
Primary Completion Date November 30, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
IRAP concentration during OGTT. At the first visit (Day 0)
Secondary Outcome
Measure Time Frame
Kinetic profile of IRAP concentration in 3-hours OGTT At the first visit (Day 0)
Diagnostic value of IRAP At the first visit (Day 0)
Diagnostic value of IRAP At the first visit (Day 0)
Diagnostic value of IRAP At the first visit (Day 0)
Diagnostic value of the concentration of other biomarkers (not yet determined) During the first visit (Day 0)
Enrollment 100
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Dosage of IRAP during OGTT

Description: Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp

Arm group label: Experimental

Eligibility

Criteria:

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

Gender: All

Minimum age: 40 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Serge BOTTARI, MD/PHD

Phone: 04 76 63 71 11

Phone ext: 33

Email: [email protected]

Location
facility contact
Service de Nutrition clinique et CRNH Auvergne | Clermont-Ferrand, France Yves BOIRIE, MD/PHD
Inserm CIC1406, clinical research center, Grenoble Alpes university hospital | Grenoble, 38043, France Jean-Luc CRACOWSKI, MD/PHD
CRNH Rhône-Alpes et Centre Hospitalier LYON Sud | Lyon, 69000, France Martine Laville, MD/PHD
Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER | Montpellier, France Eric RENARD, MD/PHD
Location Countries

France

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Experimental

Arm group type: Other

Acronym IRAP-IR
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov