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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 : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date October 17, 2016
First Posted Date October 21, 2016
Last Update Posted Date April 17, 2019
Actual Study Start Date April 7, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02941874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 20, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 20, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein
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)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Insulin Resistance
Intervention 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
Study Groups/Cohorts Healthy volunteers IRAP measurement
Intervention: Other: Blood sample collection during an OGTT to assess IRAP blood concentration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 20, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Bottari Serge, MD, PHD 04 76 63 71 11 ext +33 sbottari@chu-grenoble.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02941874
Other Study ID Numbers 38RC16.131
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Grenoble
Verification Date April 2019