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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04028895
• Collaborator: (none)
• Enrollment: 21
• Locations: 4
• Arm: 1
• Actual Duration (Months): 21.5
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Syndrome	Diagnostic Test: Dosage of IRAP during OGTT	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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)
• Actual Study Start Date: Sep 14, 2020
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. IRAP concentration during OGTT. [At the first visit (Day 0)]

   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.

Secondary Outcome Measures

1. Kinetic profile of IRAP concentration in 3-hours OGTT [At the first visit (Day 0)]

   Evolution of the concentration of IRAP at each point of the OGTT.

2. Diagnostic value of IRAP [At the first visit (Day 0)]

   Comparison of AUC (area under curve) of IRAP's ROC curves with that of insulin.

3. Diagnostic value of IRAP [At the first visit (Day 0)]

   Comparison of AUC (area under curve) of IRAP's ROC curves with that of glucose.

4. Diagnostic value of IRAP [At the first visit (Day 0)]

   Comparison of AUC (area under curve) of IRAP's ROC curves with that of resistance indexes.

5. Diagnostic value of the concentration of other biomarkers (not yet determined) [During the first visit (Day 0)]

   The diagnostic value of other potential insulin resistance biomarkers will be tested using the same methodology as for IRAP.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Nutrition clinique et CRNH Auvergne	Clermont-Ferrand		France
2	Inserm CIC1406, clinical research center, Grenoble Alpes university hospital	Grenoble		France	38043
3	CRNH Rhône-Alpes et Centre Hospitalier LYON Sud	Lyon		France	69000
4	Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER	Montpellier		France

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT04028895
• Other Study ID Numbers: 38RC18.326
• First Posted: Jul 23, 2019
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Grenoble: IRAP; Insulin Regulated Amino Peptidase
• Additional relevant MeSH terms: Insulin Resistance; Metabolic Syndrome

Study Results

No Results Posted as of Aug 11, 2022