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Trial record 17 of 667 for:    Recruiting, Not yet recruiting, Available Studies | "Insulins"

Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein (IRAP)

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ClinicalTrials.gov Identifier: NCT02941874
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The purpose of this study is on one hand to verify the measurement conformity of the IRAP dosage and on the other hand to obtain normal values of the blood IRAP concentration on healthy volunteers.

Condition or disease Intervention/treatment
Insulin Resistance Other: Blood sample collection during an OGTT to assess IRAP blood concentration

Detailed Description:

This study consists of two visits, from two to five days apart.

The first visit :

  • Healthy volunteers will be on an empty stomach.
  • they will have a clinical examination, blood tests and blood samples will be taken to constitute a blood collection. the IRAP concentration will be measured with those samples.

The second visit : This visit will take place in an interval from 2 to 5 days after the first visit.

  • Subjects will be on an empty stomach
  • An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken three time 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes to measure insulinemia, blood glucose, and IRAP concentration.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Specific Marker of the Cellular Captation of Glucose: the IRAP Protein (Insulin Regulated AminoPeptidase)
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Group/Cohort Intervention/treatment
Healthy volunteers IRAP measurement Other: Blood sample collection during an OGTT to assess IRAP blood concentration
Blood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours




Primary Outcome Measures :
  1. Normal values of IRAP concentration will be calculated by making the average of the three dosages of IRAP measured at base line. [ Time Frame: At the beginning of the second visit of the study, before the glucose intake ]
    Three blood samples will be taken 15 minutes apart, before the OGTT. The average of IRAP concentration measured with those 3 samples, will be used to assess the normal values of IRAP concentration on a healthy population.


Secondary Outcome Measures :
  1. Repeatability of the IRAP measurement [ Time Frame: At the beginning of the second visit of the study, before the glucose intake ]
    The repeatability will be assessed during the second visit. The measurement of IRAP concentration will be repeated 3 times on the first sample taken before the OGTT.

  2. Temporal reproducibility of the concentration of IRAP [ Time Frame: At the beginning of the second visit of the study, before the glucose intake ]
    The reproducibility will be assessed during the second visit. The measurement of IRAP concentration will be repeated 3 times on the first sample taken before the OGTT.


Other Outcome Measures:
  1. kinetic profile of the concentration of IRAP during OGTT [ Time Frame: During the 3 hours OGTT at the second visit ]
    Evolution of the serum concentration of IRAP during the 3 hours which follow the ingestion of 75g of glucose.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects distributed according to 3 age groups (40-49 years old , 50-59 years old, 60-70 years old). Every age bracket will be balanced in sex.
Criteria

Inclusion Criteria:

  • Body mass index between 19 and 25 Kg/m²
  • No intercurrent disease during the last week
  • No chronic infectious disease
  • No smoker, no alcoholic

Exclusion Criteria:

  • history of : thyroid disease, liver or renal disease, endocrine and metabolic disease, cardiovascular disease, lung disease, gastroenterological disorders, psychiatric disease, Epilepsy
  • Consumption of narcotic drug
  • Blood donation dating less than 2 months
  • Pregnancy or breast-feeding, or intent to become pregnant during the study period
  • legal exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941874


Contacts
Contact: Bottari Serge, MD, PHD 04 76 63 71 11 ext +33 sbottari@chu-grenoble.fr

Locations
France
Institut de Biologie - Pathologie Recruiting
Grenoble, Isere, France, 38043
Contact: Bottari Serge, MD, PHD    0476637111 ext 33    SBottari@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02941874     History of Changes
Other Study ID Numbers: 38RC16.131
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by University Hospital, Grenoble:
IRAP
Insulin Regulated Amino Peptidase
Diagnostic biomarker
Type 2 diabetes

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases