Insulin Resistance Syndrome Clinical Trial
— IRAP-IROfficial 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)
Verified date | August 2022 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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) |
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