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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01648478
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : September 11, 2014
Cisbio Bioassays
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Single Arm 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 and a second level at 2 during 4 hours ( to obtain stable hyperinsulinemia)
  • The infusion of glucose at variable rate (so as to maintain euglycemia)

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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

  2. Oxydative stress markers [ Time Frame: at T0, T120 and T240 min ]
    TBARS, GSH, GSSG and nitroalbumin assessments

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01648478

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Centre de recherche en nutrition humaine Rhone-Alpes
Pierre Bénite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Cisbio Bioassays
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Principal Investigator: Martine LAVILLE, Pr Centre de recherche en nutrition humaine Rhone-Alpes

Additional Information:
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Responsible Party: Hospices Civils de Lyon Identifier: NCT01648478    
Other Study ID Numbers: 2011.705
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Keywords provided by Hospices Civils de Lyon:
insulin sensitivity marker
Additional relevant MeSH terms:
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Insulin Resistance
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs