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

This study is currently recruiting participants.
Verified April 2012 by Hospices Civils de Lyon
Sponsor:
Collaborator:
Cisbio Bioassays
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01648478
First received: June 27, 2012
Last updated: January 17, 2013
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Insulin Resistance
 Other: It is a hyperinsulinemic-euglycemic clamp.

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
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)
Arms Assigned Interventions
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 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)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648478

Contacts
Contact: Martine LAVILLE, Pr +33478862981 martine.laville@chu-lyon.fr
Contact: Stéphanie Lambert-Porcheron, Dr + 33478861972 stephanie.lambertporcheron@chu-lyon.fr

Locations
France
Centre de recherche en nutrition humaine Rhone-Alpes Recruiting
Pierre Bénite, France
Contact: Martine LAVILLE, Pr     +33478862981     martine.laville@chu-lyon.fr    
Contact: Stéphanie LAMBERT-PORCHERON, Dr     + 33478861972     stephanie.lambertporcheron@chu-lyon.fr    
Sponsors and Collaborators
Hospices Civils de Lyon
Cisbio Bioassays
Investigators
Principal Investigator: Martine LAVILLE, Pr Centre de recherche en nutrition humaine Rhone-Alpes
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01648478     History of Changes
Other Study ID Numbers: 2011.705
Study First Received: June 27, 2012
Last Updated: January 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
IRAP
insulin sensitivity marker

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013