Insulin ResistanceIRACTIVNCT05329337
Link Between the Peripheral Mononuclear Cells' Capacity to Induce Insulin Resistance and Hyperinsulinemia
A study testing Blood test in people with Insulin Resistance and Hyperinsulinism, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Caisse Primaire d'Assurance Maladie du Gard (health insurance fund). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance, Hyperinsulinism, Immune System
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Jun 2022to 5 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who participated in the MetACTIV study.
- Profile 2 subgroup-specific inclusion criteria:
- MetACTIV study individual with a Profile 2.
- Persons who have given free informed consent.
- Persons who have signed the consent form.
- Persons affiliated to or benefiting from a health insurance plan.
- Adults (≥18 years of age).
Who cannot join
- Persons participating in Category 1 research involving human subjects
- Persons in an exclusion period as determined by another study.
- Persons under court protection, guardianship or trusteeship.
- Persons who are incapable of giving consent.
- Persons for whom it is impossible to give clear information.
- Pregnant, parturient or breastfeeding woman.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire
Nîmes, Gard, 30000
Caisse Primaire d'Assurance Maladie du Gard
Nîmes, Gard, 3000
About this study
Official title: Seeking a Link Between the Capacity of Peripheral Mononuclear Cells to Induce Insulin Resistance and the Development of Hyperinsulinemia in a General Population
This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Caisse Primaire d'Assurance Maladie du Gard (health insurance fund).
The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study.
Read the detailed description
The local health insurance fund regularly offers people who have already had a free health check-up the opportunity to re-do a check-up. This invitation will be made as part of the routine, by mail. People who have participated in the MetACTIV study will be asked to participate in the present IRACTIV study ( they will be sent an information note). That way, up to 30 volunteers who previously participated in the MetACTIV study, including 10 for whom a particular profile has been identified will be recruited again in sequence.
On the day of consultation at the Gard health insurance fund, consent will be collected from subjects who have agreed to participate. The participation of the volunteers will be reduced to this single visit and 16 mL of blood will be collected on EDTA for the purpose of this study. As in the previous MetACTIV study, this blood will be transported to the Biological Resource Center at Nîmes University Hospital. From this blood, the plasma will be frozen and stored at -80°C for subsequent determination of insulin levels under the same conditions as for the MetACTIV study. Peripheral blood mononuclear cells will be frozen and, later, cultured at the Institute of Human Genetics in complete medium for 48 hours. The effect of the supernatants of these cultures on Akt phosphorylation in HepG2 cells exposed to 10nM of insulin will then be quantified by two different techniques (Western Blot and ELISA). This effect will be expressed as a percentage of inhibition compared to the phosphorylation of Akt induced by insulin alone. The insulin slope between the measurement performed in the MetACTIV study and this IRACTIV study will also be calculated and compared to the peripheral blood mononuclear cells ability to induce insulin resistance in vitro.
- Conditions
- Insulin Resistance, Hyperinsulinism, Immune System
- Being tested
- Blood test
- Keywords
- Insulin resistance
- Medical subject headings
- Insulin Resistance, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Sixteen mL of blood will be collected on EDTA for the purpose of this study
| Study group | Role | What they receive |
|---|---|---|
| 10 patients with high insulin levels (13.3 ± 9.2 microU/mL) and markers of metabolic syndrome | Experimental | These are individuals who were isolated from the previous MetACTIV study due to their specific immune profile (Profile 2) defined by 43 immune activation markers and characterized by a high percentage of differentiated T cells and activated T cells. Receives: Diagnostic Test: Blood test |
| 20 patients with other immune profiles | Active comparator | Not described Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Fasting blood glucose will be measured during a routine health evaluation and measured in mM/L.
Measured: Day 0
End-of-study insulinemia
The amount of insulin in the blood of patients will be measured during a routine health evaluation and measured in µU/L.
Measured: Month 18
Effect of peripheral blood mononuclear cell supernatant on intensity of the signal induced by insulin in hepatocytes.
Peripheral blood mononuclear cells are isolated on a Ficoll gradient and frozen. These frozen peripheral blood mononuclear cells will be sent to the Institute of Human Genetics for culture and supernatants will be recovered after 48 hours. The effect of these supernatants on insulin signaling will then be tested. To do so, they will be added or not to cultured HepG2 cells stimulated 24 hours later by 10nM insulin. After stimulation, HepG2 cells will be lysed and their total Akt and phosphorylated Akt content measured by ELISA and Western Blot. The proportion of phosphorylated Akt in HepG2 cells exposed to peripheral blood mononuclear cells supernatant will be compared with the proportion of phosphorylated Akt in HepG2 cells not exposed to peripheral blood mononuclear cells supernatant and expressed as the percentage of insulin signaling inhibition induced by the peripheral blood mononuclear cells supernatant.
Measured: Hour 48
Secondary outcomes (2)
A. Percentage inhibition of Akt phosphorylation in Profile 2 patients compared with other immune profiles.
The decrease in signal intensity induced in hepatocytes by insulin induced by peripheral blood mononuclear cell supernatant from volunteers with Profile 2 will be compared to the decrease in this intensity induced by peripheral blood mononuclear cell supernatant from volunteers with another immune activation Profile. Measured as a percentage.
Measured: Hour 48
B. Increase in insulinemia over time in Profile 2 patients compared with other immune profiles.
Insulinemia in Profile 2 volunteers, measured in µU/mL, will be compared with that of other immune profiles.
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start27 Jun 2022
- Primary completion5 Oct 2022
- Study completion5 Oct 2023
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.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Gard health insurance fund. The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study. In order to study the evolution of insulin levels in volunteers, we need to be able to ensure a longitudinal analysis, which requires a link with the MetACTIV study data for the volunteers included in the IRACTIV study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Caisse Primaire d'Assurance Maladie du Gard
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329337
- Sponsor's protocol ID
- NIMAO/2020-1/PC-01
- Other IDs
- 2021-A03189- 32
- Acronym
- IRACTIV
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kundura L, Cezar R, Ballongue E, Andre S, Michel M, Mettling C, Lozano C, Vincent T, Muller L, Lefrant JY, Roger C, Claret PG, Duvnjak S, Loubet P, Sotto A, Tran TA, Estaquier J, Corbeau P. Low Percentage of Perforin-Expressing NK Cells during Severe SARS-CoV-2 Infection: Consumption Rather than Primary Deficiency. J Immunol. 2024 Apr 1;212(7):1105-1112. doi: 10.4049/jimmunol.2300359.
PubMed 38345346
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seeking a Link Between the Capacity of Peripheral Mononuclear Cells to Induce Insulin Resistance and the Development of Hyperinsulinemia in a General Population
- ClinicalTrials.gov ID
- NCT05329337
- Acronym / sponsor ID
- IRACTIV / NIMAO/2020-1/PC-01
- Conditions
- Insulin Resistance, Hyperinsulinism, Immune System
- Keywords
- Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Caisse Primaire d'Assurance Maladie du Gard
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 15 Apr 2022 (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.
This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Caisse Primaire d'Assurance Maladie du Gard (health insurance fund).
The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study.
Detailed description
The local health insurance fund regularly offers people who have already had a free health check-up the opportunity to re-do a check-up. This invitation will be made as part of the routine, by mail. People who have participated in the MetACTIV study will be asked to participate in the present IRACTIV study ( they will be sent an information note). That way, up to 30 volunteers who previously participated in the MetACTIV study, including 10 for whom a particular profile has been identified will be recruited again in sequence.
On the day of consultation at the Gard health insurance fund, consent will be collected from subjects who have agreed to participate. The participation of the volunteers will be reduced to this single visit and 16 mL of blood will be collected on EDTA for the purpose of this study. As in the previous MetACTIV study, this blood will be transported to the Biological Resource Center at Nîmes University Hospital. From this blood, the plasma will be frozen and stored at -80°C for subsequent determination of insulin levels under the same conditions as for the MetACTIV study. Peripheral blood mononuclear cells will be frozen and, later, cultured at the Institute of Human Genetics in complete medium for 48 hours. The effect of the supernatants of these cultures on Akt phosphorylation in HepG2 cells exposed to 10nM of insulin will then be quantified by two different techniques (Western Blot and ELISA). This effect will be expressed as a percentage of inhibition compared to the phosphorylation of Akt induced by insulin alone. The insulin slope between the measurement performed in the MetACTIV study and this IRACTIV study will also be calculated and compared to the peripheral blood mononuclear cells ability to induce insulin resistance in vitro.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Gard health insurance fund. The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study. In order to study the evolution of insulin levels in volunteers, we need to be able to ensure a longitudinal analysis, which requires a link with the MetACTIV study data for the volunteers included in the IRACTIV study.
| Arm | Type | Receives |
|---|---|---|
| 10 patients with high insulin levels (13.3 ± 9.2 microU/mL) and markers of metabolic syndrome | Experimental | Diagnostic Test: Blood testThese are individuals who were isolated from the previous MetACTIV study due to their specific immune profile (Profile 2) defined by 43 immune activation markers and characterized by a high percentage of differentiated T cells and activated T cells. |
| 20 patients with other immune profiles | Active comparator | Diagnostic Test: Blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals who participated in the MetACTIV study.
- Profile 2 subgroup-specific inclusion criteria:
- MetACTIV study individual with a Profile 2.
- Persons who have given free informed consent.
- Persons who have signed the consent form.
Key exclusion criteria (6 listed)
- Persons participating in Category 1 research involving human subjects
- Persons in an exclusion period as determined by another study.
- Persons under court protection, guardianship or trusteeship.
- Persons who are incapable of giving consent.
- Persons for whom it is impossible to give clear information.
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 testSixteen mL of blood will be collected on EDTA for the purpose of this study | Diagnostic test | 10 patients with high insulin levels (13.3 ± 9.2 microU/mL) and markers of metabolic syndrome, 20 patients with other immune profiles |
Primary outcome
Fasting blood glucose
Time frame: Day 0
Fasting blood glucose will be measured during a routine health evaluation and measured in mM/L.
End-of-study insulinemia
Time frame: Month 18
The amount of insulin in the blood of patients will be measured during a routine health evaluation and measured in µU/L.
Effect of peripheral blood mononuclear cell supernatant on intensity of the signal induced by insulin in hepatocytes.
Time frame: Hour 48
Peripheral blood mononuclear cells are isolated on a Ficoll gradient and frozen. These frozen peripheral blood mononuclear cells will be sent to the Institute of Human Genetics for culture and supernatants will be recovered after 48 hours. The effect of these supernatants on insulin signaling will then be tested. To do so, they will be added or not to cultured HepG2 cells stimulated 24 hours later by 10nM insulin. After stimulation, HepG2 cells will be lysed and their total Akt and phosphorylated Akt content measured by ELISA and Western Blot. The proportion of phosphorylated Akt in HepG2 cells exposed to peripheral blood mononuclear cells supernatant will be compared with the proportion of phosphorylated Akt in HepG2 cells not exposed to peripheral blood mononuclear cells supernatant and expressed as the percentage of insulin signaling inhibition induced by the peripheral blood mononuclear cells supernatant.
2 secondary outcomes
A. Percentage inhibition of Akt phosphorylation in Profile 2 patients compared with other immune profiles.
Time frame: Hour 48
B. Increase in insulinemia over time in Profile 2 patients compared with other immune profiles.
Time frame: Month 18
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 10 Dec 2025.
- Results publication: PubMed 38345346Kundura L, Cezar R, Ballongue E, Andre S, Michel M, Mettling C, Lozano C, Vincent T, Muller L, Lefrant JY, Roger C, Claret PG, Duvnjak S, Loubet P, Sotto A, Tran TA, Estaquier J, Corbeau P. Low Percentage of Perforin-Expressing NK Cells during Severe SARS-CoV-2 Infection: Consumption Rather than Primary Deficiency. J Immunol. 2024 Apr 1;212(7):1105-1112. doi: 10.4049/jimmunol.2300359.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Insulin Resistance and Hyperinsulinism, run by Centre Hospitalier Universitaire de Nīmes at 2 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 7 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Fasting blood glucose (time frame: Day 0). The study lists 3 primary outcomes in all. 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 NCT05329337, 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 10 Dec 2025.