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

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
It is a hyperinsulinemic-euglycemic clamp.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring IRAP, insulin sensitivity marker

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de recherche en nutrition humaine Rhone-Alpes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

IRAP plasma concentration during the hyperinsulinemic euglycemic clamp
Enzyme-linked Immunosorbsent assay (Sandwich ELISA)

Secondary Outcome Measures

Glucose Infusion Rate (GIR)
It is an average rate of glucose infused at steady state of the first and second level of insulinemia infusion
Oxydative stress markers
TBARS, GSH, GSSG and nitroalbumin assessments

Full Information

First Posted
June 27, 2012
Last Updated
September 10, 2014
Sponsor
Hospices Civils de Lyon
Collaborators
Cisbio Bioassays
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1. Study Identification

Unique Protocol Identification Number
NCT01648478
Brief Title
IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker
Acronym
IRAP
Official Title
Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
Cisbio Bioassays

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
IRAP, insulin sensitivity marker

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
It is a hyperinsulinemic-euglycemic clamp.
Intervention Description
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)
Primary Outcome Measure Information:
Title
IRAP plasma concentration during the hyperinsulinemic euglycemic clamp
Description
Enzyme-linked Immunosorbsent assay (Sandwich ELISA)
Time Frame
30 min before the clamp and during the clamp every 10 min for a duration of 240 min.
Secondary Outcome Measure Information:
Title
Glucose Infusion Rate (GIR)
Description
It is an average rate of glucose infused at steady state of the first and second level of insulinemia infusion
Time Frame
at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes
Title
Oxydative stress markers
Description
TBARS, GSH, GSSG and nitroalbumin assessments
Time Frame
at T0, T120 and T240 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine LAVILLE, Pr
Organizational Affiliation
Centre de recherche en nutrition humaine Rhone-Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche en nutrition humaine Rhone-Alpes
City
Pierre Bénite
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.crnh-rhone-alpes.fr
Description
Related Info

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

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