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

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Insulin Resistance Syndrome

Treatments: Diagnostic Test: Dosage of IRAP during OGTT

Study type: Interventional

Funder types: Other

Identifiers

NCT04028895

38RC18.326

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

Experimental

Other group

Treatment:

Diagnostic Test: Dosage of IRAP during OGTT