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

Insulin Resistance Clinical Trial

— IRAP  

Official title:

Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648478
• Other study ID #: 2011.705
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: September 10, 2014
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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)

Locations

Country	Name	City	State
France	Centre de recherche en nutrition humaine Rhone-Alpes	Pierre Bénite

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Cisbio Bioassays

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IRAP plasma concentration during the hyperinsulinemic euglycemic clamp	Enzyme-linked Immunosorbsent assay (Sandwich ELISA)	30 min before the clamp and during the clamp every 10 min for a duration of 240 min.	No
Secondary	Glucose Infusion Rate (GIR)	It is an average rate of glucose infused at steady state of the first and second level of insulinemia infusion	at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes	No
Secondary	Oxydative stress markers	TBARS, GSH, GSSG and nitroalbumin assessments	at T0, T120 and T240 min	No

External Links

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