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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01648478

Acronym

IRAP

Enrollment

Registered

2012-07-24

Start date

2012-06-01

Completion date

2012-09-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

IRAP, insulin sensitivity marker

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.

Interventions

OTHERIt 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMartine LAVILLE, Pr

Centre de recherche en nutrition humaine Rhone-Alpes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026