Insulin ResistanceIRAPNCT02941874
Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Marker of the Cellular Captation of Glucose: the IRAP Protein
An observational study of Insulin Resistance, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Blood sample collection during an OGTT to assess IRAP blood concentration
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2017to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Body mass index between 19 and 25 Kg/m²
- No intercurrent disease during the last week
- No chronic infectious disease
- No smoker, no alcoholic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- Blood sample collection during an OGTT to assess IRAP blood concentration
- Keywords
- IRAP, Insulin Regulated Amino Peptidase, Diagnostic biomarker, Type 2 diabetes
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection during an OGTT to assess IRAP blood concentrationOther
Blood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers IRAP measurement | Not described Receives: Other: Blood sample collection during an OGTT to assess IRAP blood concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal values of IRAP concentration will be calculated by making the average of the three dosages of IRAP measured at base line.
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.
Measured: At the beginning of the second visit of the study, before the glucose intake
Secondary outcomes (2)
Repeatability of the IRAP measurement
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.
Measured: At the beginning of the second visit of the study, before the glucose intake
Temporal reproducibility of the concentration of IRAP
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.
Measured: At the beginning of the second visit of the study, before the glucose intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start7 Apr 2017
- Primary completion16 Sep 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941874
- Sponsor's protocol ID
- 38RC16.131
- Acronym
- IRAP
- Status last verified
- Nov 2020
- First submitted
- 17 Oct 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02941874
- Acronym / sponsor ID
- IRAP / 38RC16.131
- Conditions
- Insulin Resistance
- Keywords
- IRAP, Insulin Regulated Amino Peptidase, Diagnostic biomarker, Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers IRAP measurement | – | Other: Blood sample collection during an OGTT to assess IRAP blood concentration |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Body mass index between 19 and 25 Kg/m²
- No intercurrent disease during the last week
- No chronic infectious disease
- No smoker, no alcoholic
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collection during an OGTT to assess IRAP blood concentrationBlood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours | Other | Healthy volunteers IRAP measurement |
Primary outcome
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.
2 secondary outcomes
Repeatability of the IRAP measurement
Time frame: At the beginning of the second visit of the study, before the glucose intake
Temporal reproducibility of the concentration of IRAP
Time frame: At the beginning of the second visit of the study, before the glucose intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.