Link Between the Peripheral Mononuclear Cells' Capacity to Induce Insulin Resistance and Hyperinsulinemia (IRACTIV)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Hyperinsulinism; Insulin Resistance; Immune System

Treatments: Diagnostic Test: Blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT05329337

NIMAO/2020-1/PC-01

2021-A03189- 32 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

10 patients with high insulin levels (13.3 ± 9.2 microU/mL) and markers of metabolic syndrome

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Blood test

20 patients with other immune profiles

Active Comparator group

Treatment:

Diagnostic Test: Blood test