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

Insulin Resistance Syndrome Clinical Trial

— IRAP-IR  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04028895
• Other study ID #: 38RC18.326
• Status: Terminated
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Resistance Syndrome
• Metabolic Syndrome

Intervention

Diagnostic Test:
• Dosage of IRAP during OGTT
Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)