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Completed

NCT Number: NCT01648478

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

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche en nutrition humaine Rhone-Alpes

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

It is a hyperinsulinemic-euglycemic clamp.

Other

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 outcomes

  1. 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.

    Enzyme-linked Immunosorbsent assay (Sandwich ELISA)

Secondary outcomes

  1. Glucose Infusion Rate (GIR)

    Time frame: 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

  2. Oxydative stress markers

    Time frame: at T0, T120 and T240 min

    TBARS, GSH, GSSG and nitroalbumin assessments

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Cisbio Bioassays

Registry information

Official study title

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

Acronym: IRAP

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 24, 2012
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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