NCT01648478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

June 27, 2012

Last Update Submit

April 20, 2026

Conditions

Insulin Resistance

Keywords

IRAPinsulin sensitivity marker

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Glucose Infusion Rate (GIR)

    at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes

  • Oxydative stress markers

    at T0, T120 and T240 min

Study Arms (1)

Single Arm

EXPERIMENTAL
Other: It is a hyperinsulinemic-euglycemic clamp.

Interventions

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)

Single Arm

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche en nutrition humaine Rhone-Alpes

Pierre-Bénite, France

Location

Related Publications (1)

  • Trocme C, Gonnet N, Di Tommaso M, Samouda H, Cracowski JL, Cracowski C, Lambert-Porcheron S, Laville M, Nobecourt E, Gaddhab C, Le Lay A, Bohn T, Poitou C, Clement K, Al-Mulla F, Bitar MS, Bottari SP. Serum IRAP, a Novel Direct Biomarker of Prediabetes and Type 2 Diabetes? Front Mol Biosci. 2021 Feb 16;7:596141. doi: 10.3389/fmolb.2020.596141. eCollection 2020.

    PMID: 33665204RESULT

Related Links

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Martine LAVILLE, Pr

    Centre de recherche en nutrition humaine Rhone-Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 24, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

FR(1)