Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance (IRAP-IR)
Primary Purpose
Insulin Resistance Syndrome
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dosage of IRAP during OGTT
Sponsored by
About this trial
This is an interventional diagnostic trial for Insulin Resistance Syndrome focused on measuring IRAP, Insulin Regulated Amino Peptidase
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
Sites / Locations
- Service de Nutrition clinique et CRNH Auvergne
- Inserm CIC1406, clinical research center, Grenoble Alpes university hospital
- CRNH Rhône-Alpes et Centre Hospitalier LYON Sud
- Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Experimental
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Kinetic profile of IRAP concentration in 3-hours OGTT
Evolution of the concentration of IRAP at each point of the OGTT.
Diagnostic value of IRAP
Comparison of AUC (area under curve) of IRAP's ROC curves with that of insulin.
Diagnostic value of IRAP
Comparison of AUC (area under curve) of IRAP's ROC curves with that of glucose.
Diagnostic value of IRAP
Comparison of AUC (area under curve) of IRAP's ROC curves with that of resistance indexes.
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.
Full Information
NCT ID
NCT04028895
First Posted
May 23, 2019
Last Updated
August 8, 2022
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04028895
Brief Title
Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
stopped by the sponsor
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance Syndrome
Keywords
IRAP, Insulin Regulated Amino Peptidase
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Dosage of IRAP during OGTT
Intervention Description
Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp
Primary Outcome Measure Information:
Title
IRAP concentration during OGTT.
Description
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.
Time Frame
At the first visit (Day 0)
Secondary Outcome Measure Information:
Title
Kinetic profile of IRAP concentration in 3-hours OGTT
Description
Evolution of the concentration of IRAP at each point of the OGTT.
Time Frame
At the first visit (Day 0)
Title
Diagnostic value of IRAP
Description
Comparison of AUC (area under curve) of IRAP's ROC curves with that of insulin.
Time Frame
At the first visit (Day 0)
Title
Diagnostic value of IRAP
Description
Comparison of AUC (area under curve) of IRAP's ROC curves with that of glucose.
Time Frame
At the first visit (Day 0)
Title
Diagnostic value of IRAP
Description
Comparison of AUC (area under curve) of IRAP's ROC curves with that of resistance indexes.
Time Frame
At the first visit (Day 0)
Title
Diagnostic value of the concentration of other biomarkers (not yet determined)
Description
The diagnostic value of other potential insulin resistance biomarkers will be tested using the same methodology as for IRAP.
Time Frame
During the first visit (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Service de Nutrition clinique et CRNH Auvergne
City
Clermont-Ferrand
Country
France
Facility Name
Inserm CIC1406, clinical research center, Grenoble Alpes university hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CRNH Rhône-Alpes et Centre Hospitalier LYON Sud
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER
City
Montpellier
Country
France
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance
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