Clinical trial NCT05329337: Link Between the Peripheral Mononuclear Cells' Capacity to Induce Insulin Resistance and Hyperinsulinemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Hyperinsulinism
Immune System
Keywords: Insulin resistance
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Caisse Primaire d'Assurance Maladie du Gard
First posted: 2022-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fasting blood glucose
timeFrame: Day 0
measure: End-of-study insulinemia
timeFrame: Month 18
measure: Effect of peripheral blood mononuclear cell supernatant on intensity of the signal induced by insulin in hepatocytes.
timeFrame: Hour 48
Secondary outcomes:
measure: A. Percentage inhibition of Akt phosphorylation in Profile 2 patients compared with other immune profiles.
timeFrame: Hour 48
measure: B. Increase in insulinemia over time in Profile 2 patients compared with other immune profiles.
timeFrame: Month 18
Other outcomes:
measure: Age of Profile 2 patients
timeFrame: Day 0
measure: Weight of profile 2 patients
timeFrame: Day 0
measure: Gender of Profile 2 patients
timeFrame: Day 0
measure: Waist measurement of Profile 2 patients
timeFrame: Day 0
measure: Hip circumference of Profile 2 patients
timeFrame: Day 0
measure: Systolic blood pressure in Profile 2 patients
timeFrame: Day 0
measure: Diastolic blood pressure in Profile 2 patients
timeFrame: Day 0
measure: High-density lipoproteins in Profile 2 patients
timeFrame: Day 0
measure: Low-density lipoproteins in Profile 2 patients
timeFrame: Day 0
measure: Triglycerides in Profile 2 patients
timeFrame: Day 0
measure: Hemoglobin A1c in Profile 2 patients
timeFrame: Day 0
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire
state: Gard
city: Nîmes
country: France
facility: Caisse Primaire d'Assurance Maladie du Gard
state: Gard
Study officials:
References: