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IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker (IRAP)

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ClinicalTrials.gov Identifier: NCT01648478
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : September 11, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 27, 2012
July 24, 2012
September 11, 2014
June 2012
July 2012   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01648478 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker
Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Insulin Resistance
Other: It is a hyperinsulinemic-euglycemic clamp.

The hyperinsulinemic-euglycemic clamp includes three periods:

  • A basal period (from T-30 to T0)
  • The infusion of insulin at a constant rate (first level at 1 mUI.kg-1.min-1 and a second level at 2 mUI.kg-1.min-1) during 4 hours ( to obtain stable hyperinsulinemia)
  • The infusion of glucose at variable rate (so as to maintain euglycemia)
Experimental: Single Arm
Intervention: Other: It is a hyperinsulinemic-euglycemic clamp.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women (sex ratio = 1)
  • Aged from 18 to 35 years
  • Fasting glycemia < 6mmol/L
  • Total cholesterol < 7mmol/L
  • Triglycerides < 1.5 mmol/L
  • CRPus < 5 mg/L
  • Creatinine clearance < 80mL/min according to Cockroft formula
  • Liver enzymes (ALanine AminoTransférase and ASpartate AminoTransférase) < 1.5 times normal values

Exclusion Criteria:

  • Subject not in compliance with the recommendations of French National Law in force
  • Medical history of metabolic disease (diabetes, dyslipidemia), endocrine disease, renal insufficiency
  • Drug use that could affect glucose metabolism and the renin angiotensin aldosterone system
  • Blood pressure > 140/90mmHg
  • Tea and coffee consumption more than 5 cups per day
  • Subject who smoke more than 5 cigarettes per day
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01648478
2011.705
No
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Cisbio Bioassays
Principal Investigator: Martine LAVILLE, Pr Centre de recherche en nutrition humaine Rhone-Alpes
Hospices Civils de Lyon
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP