IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker (IRAP)
|ClinicalTrials.gov Identifier: NCT01648478|
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : September 11, 2014
Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin. The extracellular domain of IRAP is cleaved and released in the bloodstream.
Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.
In this study the investigators seek to confirm this hypothesis by using the gold standard of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.
It is a multicenter descriptive study.
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Other: It is a hyperinsulinemic-euglycemic clamp.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||September 2012|
|Experimental: Single Arm||
Other: It is a hyperinsulinemic-euglycemic clamp.
The hyperinsulinemic-euglycemic clamp includes three periods:
- IRAP plasma concentration during the hyperinsulinemic euglycemic clamp [ Time Frame: 30 min before the clamp and during the clamp every 10 min for a duration of 240 min. ]Enzyme-linked Immunosorbsent assay (Sandwich ELISA)
- Glucose Infusion Rate (GIR) [ Time Frame: at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes ]It is an average rate of glucose infused at steady state of the first and second level of insulinemia infusion
- Oxydative stress markers [ Time Frame: at T0, T120 and T240 min ]TBARS, GSH, GSSG and nitroalbumin assessments
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648478
|Centre de recherche en nutrition humaine Rhone-Alpes|
|Pierre Bénite, France|
|Principal Investigator:||Martine LAVILLE, Pr||Centre de recherche en nutrition humaine Rhone-Alpes|