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Completed

NCT Number: NCT02941874

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

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.

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Key information

Conditions

Insulin Resistance Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Biologie - Pathologie

Grenoble, Isere, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Blood sample collection during an OGTT to assess IRAP blood concentration

Other

Blood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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)

Acronym: IRAP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2016
Registry last updated
Nov 4, 2020

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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