Clinical trial NCT04028895: Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insulin Resistance Syndrome
Keywords: IRAP
Insulin Regulated Amino Peptidase
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: IRAP concentration during OGTT.
timeFrame: At the first visit (Day 0)
Secondary outcomes:
measure: Kinetic profile of IRAP concentration in 3-hours OGTT
timeFrame: At the first visit (Day 0)
measure: Diagnostic value of IRAP
timeFrame: At the first visit (Day 0)
measure: Diagnostic value of IRAP
timeFrame: At the first visit (Day 0)
measure: Diagnostic value of IRAP
timeFrame: At the first visit (Day 0)
measure: Diagnostic value of the concentration of other biomarkers (not yet determined)
timeFrame: During the first visit (Day 0)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Service de Nutrition clinique et CRNH Auvergne
city: Grenoble
country: France
facility: Inserm CIC1406, clinical research center, Grenoble Alpes university hospital
city: Lyon
country: France
facility: CRNH Rhône-Alpes et Centre Hospitalier LYON Sud
city: Montpellier
country: France
facility: Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER
Study officials:
References: