Skip to main content
OpenTrials
Completed

NCT Number: NCT05329337

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Immune System Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caisse Primaire d'Assurance Maladie du Gard, Nîmes, Gard, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood test

Diagnostic Test

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

Primary outcomes

  1. Fasting blood glucose

    Time frame: Day 0

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

  2. 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.

  3. 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.

Secondary outcomes

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

    Time frame: Hour 48

    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.

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

    Time frame: Month 18

    Insulinemia in Profile 2 volunteers, measured in µU/mL, will be compared with that of other immune profiles.

Other outcomes

  1. Age of Profile 2 patients

    Time frame: Day 0

    In years

  2. Weight of profile 2 patients

    Time frame: Day 0

    In kg

  3. Gender of Profile 2 patients

    Time frame: Day 0

    male / female

  4. Waist measurement of Profile 2 patients

    Time frame: Day 0

    In cm

  5. Hip circumference of Profile 2 patients

    Time frame: Day 0

    In cm

  6. Systolic blood pressure in Profile 2 patients

    Time frame: Day 0

    In mmHg

  7. Diastolic blood pressure in Profile 2 patients

    Time frame: Day 0

    In mmHg

  8. High-density lipoproteins in Profile 2 patients

    Time frame: Day 0

    mM/L

  9. Low-density lipoproteins in Profile 2 patients

    Time frame: Day 0

    mM/L

  10. Triglycerides in Profile 2 patients

    Time frame: Day 0

    mM/L

  11. Hemoglobin A1c in Profile 2 patients

    Time frame: Day 0

    mM/L

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Caisse Primaire d'Assurance Maladie du Gard

Registry information

Official study title

Seeking a Link Between the Capacity of Peripheral Mononuclear Cells to Induce Insulin Resistance and the Development of Hyperinsulinemia in a General Population

Acronym: IRACTIV

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 15, 2022
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.