IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker
Recruitment status was Recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp|
- 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]TBARS, GSH, GSSG and nitroalbumin assessments
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm||
Other: It is a hyperinsulinemic-euglycemic clamp.
The hyperinsulinemic-euglycemic clamp includes three periods:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648478
|Contact: Martine LAVILLE, Premail@example.com|
|Contact: Stéphanie Lambert-Porcheron, Dr||+ firstname.lastname@example.org|
|Centre de recherche en nutrition humaine Rhone-Alpes||Recruiting|
|Pierre Bénite, France|
|Contact: Martine LAVILLE, Pr +33478862981 email@example.com|
|Contact: Stéphanie LAMBERT-PORCHERON, Dr + 33478861972 firstname.lastname@example.org|
|Principal Investigator:||Martine LAVILLE, Pr||Centre de recherche en nutrition humaine Rhone-Alpes|