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

NCT04028895 | Terminated

• 1 other identifier: 38RC18.326
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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).

Conditions

Insulin Resistance Syndrome

Keywords

IRAP; Insulin Regulated Amino Peptidase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (1)

Experimental

OTHER

Diagnostic Test: Dosage of IRAP during OGTT

Interventions

Dosage of IRAP during OGTT DIAGNOSTIC_TEST

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

Experimental

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (4)

Service de Nutrition clinique et CRNH Auvergne

Clermont-Ferrand, France

Location

Inserm CIC1406, clinical research center, Grenoble Alpes university hospital

Grenoble, 38043, France

Location

CRNH Rhône-Alpes et Centre Hospitalier LYON Sud

Lyon, 69000, France

Location

Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER

Montpellier, France

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: July 23, 2019
• Study Start: September 14, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

FR (4)