Diagnostic Interest of the IRAP Protein (Insulin Regulate... | NCT04028895

Studies
Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance

NCT04028895

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Aug 11, 2022Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Insulin Resistance Syndrome

Interventions

Dosage of IRAP during OGTT

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

stopped by the sponsor

Expanded Access Info

Start Date

Sep 14, 2020Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

Jul 22, 2019

First Posted Date

Jul 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2022

Last Update Posted Date

Aug 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There is currently no reliable, diagnostic tests of insulin resistance other than the hyperinsulinemic euglycemic clamp which, due to its constraints and cost, is reserved for research. The insulin-Regulated aminopeptidase (IRAP) protein is a direct marker of insulin-dependent glucose cell capture and thus it blood concentration seems to be a good diagnostic test of insulin resistance.

The purpose of this study is to assess a plasma essay of IRAP protein for evaluation of insulin resistance during an oral glucose tolerance test (OGTT).

Detailed Description

This study consists of two visits, from three to fifteen days apart. Patients with different levels of insulin resistance will be enrolled in this study.

The level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp that will be performed at the second visit.

The first visit :

Subjects will be on an empty stomach
A blood test including HbA1C, C-Peptid, lipid profile, creatinine,urea, hepatic workup
An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken two time (T-15', T0) 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes (T15', T30', T 45', T60', T75', T90', T105', T120' and 180') to measure insulinemia, blood sugar, and IRAP concentration.

The second visit includes a 3-hours hyperinsulinemic euglycemic clamp.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Other		Diagnostic Test: Dosage of IRAP during OGTT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dosage of IRAP during OGTT	Diagnostic Test	Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IRAP concentration during OGTT.	The level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp. The specificity and sensitivity of the IRAP concentration for the diagnosis of insulin resistance will be determined at every time of the OGTT.	At the first visit (Day 0)

Secondary Outcomes

Measure	Description	Time Frame
Kinetic profile of IRAP concentration in 3-hours OGTT	Evolution of the concentration of IRAP at each point of the OGTT.	At the first visit (Day 0)
Diagnostic value of IRAP	Comparison of AUC (area under curve) of IRAP's ROC curves with that of insulin.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient without known diabetes
Abdominal perimeter greater than 80 cm for women and greater than 94 cm for men
Patient affiliated to social security insurance or beneficiary of social security insurance.
Signed consent

Exclusion Criteria:

Consumption of narcotic
Medication that may interfere with glucose metabolism
History of bariatric surgery
Known acute or chronic renal insufficiency
Hyperinsulinemic euglycemic clamp contraindication
Contraindications with insulin, G20 glucose and Di-potassium phosphate
Histories of coronary pathology
History of heart rhythm disorders requiring chronic treatment
Period of fast
Pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Nutrition clinique et CRNH Auvergne		Clermont-Ferrand			France
Inserm CIC1406, clinical research center, Grenoble Alpes university hospital

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

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