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

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Other: It is a hyperinsulinemic-euglycemic clamp.

• Registration Number: NCT01648478
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-27
• Primary Completion: 2012-07
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Study Completion: 2012-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	It is a hyperinsulinemic-euglycemic clamp.	-

Primary Outcome Measures

Name	Time	Method
IRAP plasma concentration during the hyperinsulinemic euglycemic clamp	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

Name	Time	Method
Glucose Infusion Rate (GIR)	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	at T0, T120 and T240 min	TBARS, GSH, GSSG and nitroalbumin assessments

Trial Locations

Locations (1)

Centre de recherche en nutrition humaine Rhone-Alpes; 🇫🇷 Pierre Bénite, France