Insulin ResistanceIRAPNCT01648478
IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker
A study testing It is a hyperinsulinemic-euglycemic clamp. in people with Insulin Resistance, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- It is a hyperinsulinemic-euglycemic clamp.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Sep 2012
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women (sex ratio = 1)
- Aged from 18 to 35 years
- Fasting glycemia < 6mmol/L
- Total cholesterol < 7mmol/L
- Triglycerides < 1.5 mmol/L
- CRPus < 5 mg/L
- Creatinine clearance < 80mL/min according to Cockroft formula
- Liver enzymes (ALanine AminoTransférase and ASpartate AminoTransférase) < 1.5 times normal values
Who cannot join
- Subject not in compliance with the recommendations of French National Law in force
- Medical history of metabolic disease (diabetes, dyslipidemia), endocrine disease, renal insufficiency
- Drug use that could affect glucose metabolism and the renin angiotensin aldosterone system
- Blood pressure > 140/90mmHg
- Tea and coffee consumption more than 5 cups per day
- Subject who smoke more than 5 cigarettes per day
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de recherche en nutrition humaine Rhone-Alpes
Pierre-Bénite
About this study
Official title: Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp
Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin. The extracellular domain of IRAP is cleaved and released in the bloodstream.
Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.
Read more
In this study the investigators seek to confirm this hypothesis by using the gold standard of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.
It is a multicenter descriptive study.
- Conditions
- Insulin Resistance
- Being tested
- It is a hyperinsulinemic-euglycemic clamp.
- Keywords
- IRAP, insulin sensitivity marker
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It is a hyperinsulinemic-euglycemic clamp.Other
The hyperinsulinemic-euglycemic clamp includes three periods:
- A basal period (from T-30 to T0)
- The infusion of insulin at a constant rate (first level at 1 mUI.kg-1.min-1 and a second level at 2 mUI.kg-1.min-1) during 4 hours ( to obtain stable hyperinsulinemia)
- The infusion of glucose at variable rate (so as to maintain euglycemia)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Other: It is a hyperinsulinemic-euglycemic clamp. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IRAP plasma concentration during the hyperinsulinemic euglycemic clamp
Enzyme-linked Immunosorbsent assay (Sandwich ELISA)
Measured: 30 min before the clamp and during the clamp every 10 min for a duration of 240 min.
Secondary outcomes (2)
Glucose Infusion Rate (GIR)
It is an average rate of glucose infused at steady state of the first and second level of insulinemia infusion
Measured: at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes
Oxydative stress markers
TBARS, GSH, GSSG and nitroalbumin assessments
Measured: at T0, T120 and T240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Cisbio Bioassays
- Responsible party
- Sponsor
- Investigators
- Martine LAVILLE, Pr, Principal investigator, Centre de recherche en nutrition humaine Rhone-Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648478
- Sponsor's protocol ID
- 2011.705
- Acronym
- IRAP
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2012
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Trocme C, Gonnet N, Di Tommaso M, Samouda H, Cracowski JL, Cracowski C, Lambert-Porcheron S, Laville M, Nobecourt E, Gaddhab C, Le Lay A, Bohn T, Poitou C, Clement K, Al-Mulla F, Bitar MS, Bottari SP. Serum IRAP, a Novel Direct Biomarker of Prediabetes and Type 2 Diabetes? Front Mol Biosci. 2021 Feb 16;7:596141. doi: 10.3389/fmolb.2020.596141. eCollection 2020.
PubMed 33665204
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp
- ClinicalTrials.gov ID
- NCT01648478
- Acronym / sponsor ID
- IRAP / 2011.705
- Conditions
- Insulin Resistance
- Keywords
- IRAP, insulin sensitivity marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Cisbio Bioassays
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Jul 2012 (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.
Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin. The extracellular domain of IRAP is cleaved and released in the bloodstream.
Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.
In this study the investigators seek to confirm this hypothesis by using the gold standard of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.
It is a multicenter descriptive study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: It is a hyperinsulinemic-euglycemic clamp. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women (sex ratio = 1)
- Aged from 18 to 35 years
- Fasting glycemia < 6mmol/L
- Total cholesterol < 7mmol/L
- Triglycerides < 1.5 mmol/L
Key exclusion criteria (6 listed)
- Subject not in compliance with the recommendations of French National Law in force
- Medical history of metabolic disease (diabetes, dyslipidemia), endocrine disease, renal insufficiency
- Drug use that could affect glucose metabolism and the renin angiotensin aldosterone system
- Blood pressure > 140/90mmHg
- Tea and coffee consumption more than 5 cups per day
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 |
|---|---|---|
| It is a hyperinsulinemic-euglycemic clamp.The hyperinsulinemic-euglycemic clamp includes three periods: * A basal period (from T-30 to T0) * The infusion of insulin at a constant rate (first level at 1 mUI.kg-1.min-1 and a second level at 2 mUI.kg-1.min-1) during 4 hours ( to obtain stable hyperinsulinemia) * The infusion of glucose at variable rate (so as to maintain euglycemia) | Other | Single Arm |
Primary outcome
IRAP plasma concentration during the hyperinsulinemic euglycemic clamp
Time frame: 30 min before the clamp and during the clamp every 10 min for a duration of 240 min.
Enzyme-linked Immunosorbsent assay (Sandwich ELISA)
2 secondary outcomes
Glucose Infusion Rate (GIR)
Time frame: at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes
Oxydative stress markers
Time frame: at T0, T120 and T240 min
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 23 Apr 2026.
- Results publication: PubMed 33665204Trocme C, Gonnet N, Di Tommaso M, Samouda H, Cracowski JL, Cracowski C, Lambert-Porcheron S, Laville M, Nobecourt E, Gaddhab C, Le Lay A, Bohn T, Poitou C, Clement K, Al-Mulla F, Bitar MS, Bottari SP. Serum IRAP, a Novel Direct Biomarker of Prediabetes and Type 2 Diabetes? Front Mol Biosci. 2021 Feb 16;7:596141. doi: 10.3389/fmolb.2020.596141. eCollection 2020.
- Related InfoLink provided by the sponsor.
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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.
Martine LAVILLE, Pr principal investigator
Centre de recherche en nutrition humaine Rhone-Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing It is a hyperinsulinemic-euglycemic clamp. in people with Insulin Resistance, run by Hospices Civils de Lyon 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 8 inclusion and 6 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 23 Apr 2026. 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?
IRAP plasma concentration during the hyperinsulinemic euglycemic clamp (time frame: 30 min before the clamp and during the clamp every 10 min for a duration of 240 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01648478, which also lists 1 linked publication.
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 23 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.