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

NCT05329337 | Completed

• 2 other identifiers: NIMAO/2020-1/PC-012021-A03189- 32
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Insulin Resistance; Hyperinsulinism; Immune System

Keywords

Insulin resistance

Outcome Measures

Primary Outcomes (3)

• Fasting blood glucose

  Fasting blood glucose will be measured during a routine health evaluation and measured in mM/L.

  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.

  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.

  Hour 48

Secondary Outcomes (2)

• A. Percentage inhibition of Akt phosphorylation in Profile 2 patients compared with other immune profiles.

  Hour 48

• B. Increase in insulinemia over time in Profile 2 patients compared with other immune profiles.

  Month 18

Other Outcomes (11)

• Age of Profile 2 patients

  Day 0

• Weight of profile 2 patients

  Day 0

• Gender of Profile 2 patients

  Day 0

Study Arms (2)

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.

Diagnostic Test: Blood test

20 patients with other immune profiles

ACTIVE COMPARATOR

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

Sixteen mL of blood will be collected on EDTA for the purpose of this study

10 patients with high insulin levels (13.3 ± 9.2 microU/mL) and markers of metabolic syndrome; 20 patients with other immune profiles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who participated in the MetACTIV study.
• 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).

You may not qualify if:

• Persons participating in Category 1 research involving human subjects
• 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.

Sponsors & Collaborators

• Caisse Primaire d'Assurance Maladie du Gard: collaborator
• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Centre Hospitalier Universitaire

Nîmes, Gard, 30000, France

Location

Caisse Primaire d'Assurance Maladie du Gard

Nîmes, Gard, 3000, France

Location

Related Publications (1)

• 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.

  PMID: 38345346 RESULT

MeSH Terms

Conditions

Insulin Resistance; Hyperinsulinism

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 15, 2022
• Study Start: June 27, 2022
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)