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Completed

NCT Number: NCT03309761

Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69

The aim of the study is to describe an immune activation profile of people at risk of insulin resistance based on a wide range of markers which will allow easy identification of patients at risk.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases

Age range

55 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nimes, Nîmes, France

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The patient has been informed of the study, its objectives, constraints and the patient rights
  • The patient must have given their free and informed consent and signed the consent form
  • The patient is aged 55-69

Exclusion criteria

  • The subject is participating in an interventional category 1 study
  • The patient has participated in another category 1 interventional study in the last 3 months
  • The patient is in a period of exclusion determined by a previous study
  • The patient is under safeguard of justice or state guardianship
  • The subject refuses to sign the consent
  • The subject does not understand the information

Treatment and study plan

Blood Test

Other

6ml blood sample taken

Primary outcomes

  1. Cluster of Differentiation 4 (CD4+) T cell subpopulations

    Time frame: Day 0

    immunosenescence; number/mm3

  2. Cluster of Differentiation 8 (CD8+) T cell subpopulations

    Time frame: Day 0

    immunosenescence; number/mm3

  3. B cell subpopulations

    Time frame: Day 0

    flow cytometry

  4. Natural killer (NK) cell subpopulations

    Time frame: Day 0

    immunosenescence; number/mm3

  5. sCD14 level

    Time frame: Day 0

    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  6. 16 ribosomal ribonucleic acid (rRNA) levels

    Time frame: Day 0

    polymerase chain reaction (PCR); copies/µl

  7. lipopolysaccharide (LPS)-binding protein level

    Time frame: Day 0

    ELISA; µg/mL

  8. Intestinal Fatty Acid Binding Protein level

    Time frame: Day 0

    ELISA; pg/mL

  9. Total cholesterol

    Time frame: Day 0

    mM/L

  10. High Density Lipoprotein

    Time frame: Day 0

    mM/L

  11. Low Density Lipoprotein

    Time frame: Day 0

    mM/L

  12. fasting glycemia

    Time frame: Day 0

  13. fasting insulinemia

    Time frame: Day 0

    mIU/L

  14. γ-glutamyl transpeptidase level

    Time frame: Day 0

  15. glutamic pyruvic transaminase

    Time frame: Day 0

  16. hip circumference

    Time frame: Day 0

    cm

  17. waist circumference

    Time frame: Day 0

    cm

  18. minimal arterial tension

    Time frame: Day 0

    mmHg

  19. maximal arterial tension

    Time frame: Day 0

    mmHg

  20. Cluster of Differentiation 163 (CD163) level

    Time frame: Day 0

    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  21. soluble tumor necrosis factor-alpha receptor I (sTNFRI) level

    Time frame: Day 0

    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  22. soluble endothelial protein C Receptro (sEPCR) level

    Time frame: Day 0

    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  23. tissue plasminogen activator (tPa) level

    Time frame: Day 0

    ng/ml, enzyme-linked immunosorbent assays (ELISA)

Secondary outcomes

  1. Prevalence of insulin and metabolic syndrome

    Time frame: Day 0

    % subjects

  2. Link between immune activation profile and other features of metabolic syndrome

    Time frame: Day 0

    logistic regression of individual markers

  3. Immune activation linked to the profile

    Time frame: Day 0

    logistic regression

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: METACTIV

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Nov 21, 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.

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