Insulin Resistance SyndromeIRAP-IRNCT04028895
Diagnostic Interest of the IRAP Protein (Insulin Regulated Amino Peptidase) in Insulin Resistance
A study testing Dosage of IRAP during OGTT in people with Insulin Resistance Syndrome, run by University Hospital, Grenoble at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance Syndrome
- What is being tested?
- Dosage of IRAP during OGTT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Sep 2020to 30 Jun 2022
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Histories of coronary pathology
- History of heart rhythm disorders requiring chronic treatment
- Period of fast
- Pregnant women
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Nutrition clinique et CRNH Auvergne
Clermont-Ferrand
Inserm CIC1406, clinical research center, Grenoble Alpes university hospital
Grenoble, 38043
CRNH Rhône-Alpes et Centre Hospitalier LYON Sud
Lyon, 69000
Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER
Montpellier
About this study
Official title: Assessement of the Diagnostic Interest in Insulin Resistance of the Specific and Quantitative ELISA Assay of a Plasma Biomarker of Cellular Glucose Capture: the Secreted IRAP Protein (Regulated Amino Peptidase Insulin)
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).
Read the 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.
- Conditions
- Insulin Resistance Syndrome
- Being tested
- Dosage of IRAP during OGTT
- Keywords
- IRAP, Insulin Regulated Amino Peptidase
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of IRAP during OGTTDiagnostic test
Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Other | Not described Receives: Diagnostic Test: Dosage of IRAP during OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the first visit (Day 0)
Secondary outcomes (5)
Kinetic profile of IRAP concentration in 3-hours OGTT
Evolution of the concentration of IRAP at each point of the OGTT.
Measured: 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.
Measured: At the first visit (Day 0)
Diagnostic value of IRAP
Comparison of AUC (area under curve) of IRAP's ROC curves with that of glucose.
Measured: At the first visit (Day 0)
Diagnostic value of IRAP
Comparison of AUC (area under curve) of IRAP's ROC curves with that of resistance indexes.
Measured: At the first visit (Day 0)
Diagnostic value of the concentration of other biomarkers (not yet determined)
The diagnostic value of other potential insulin resistance biomarkers will be tested using the same methodology as for IRAP.
Measured: During the first visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start14 Sep 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: stopped by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Resistance SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT04028895
- Sponsor's protocol ID
- 38RC18.326
- Acronym
- IRAP-IR
- Status last verified
- Aug 2022
- First submitted
- 23 May 2019
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessement of the Diagnostic Interest in Insulin Resistance of the Specific and Quantitative ELISA Assay of a Plasma Biomarker of Cellular Glucose Capture: the Secreted IRAP Protein (Regulated Amino Peptidase Insulin)
- ClinicalTrials.gov ID
- NCT04028895
- Acronym / sponsor ID
- IRAP-IR / 38RC18.326
- Conditions
- Insulin Resistance Syndrome
- Keywords
- IRAP, Insulin Regulated Amino Peptidase
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stopped by the sponsor
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Jul 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Other | Diagnostic Test: Dosage of IRAP during OGTT |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Consumption of narcotic
- Medication that may interfere with glucose metabolism
- History of bariatric surgery
- Known acute or chronic renal insufficiency
- Hyperinsulinemic euglycemic clamp contraindication
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 |
|---|---|---|
| Dosage of IRAP during OGTTVisit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp | Diagnostic test | Experimental |
Primary outcome
IRAP concentration during OGTT.
Time frame: At the first visit (Day 0)
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.
5 secondary outcomes
Kinetic profile of IRAP concentration in 3-hours OGTT
Time frame: At the first visit (Day 0)
Diagnostic value of IRAP
Time frame: At the first visit (Day 0)
Diagnostic value of IRAP
Time frame: At the first visit (Day 0)
Diagnostic value of IRAP
Time frame: At the first visit (Day 0)
Diagnostic value of the concentration of other biomarkers (not yet determined)
Time frame: During the first visit (Day 0)
Results and safety
The study was stopped early (reason given: stopped by the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosage of IRAP during OGTT in people with Insulin Resistance Syndrome, run by University Hospital, Grenoble at 4 sites 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 10 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: stopped early, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: stopped by the sponsor). Results are not available in the source record.
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?
IRAP concentration during OGTT. (time frame: At the first visit (Day 0)). 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 11 Aug 2022.