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

November 18, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU Nîmes
      • Nîmes, France
        • Centre d'examen de santé de la Sécurité Sociale de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Volunteers aged between 55-69

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients aged 55-60
Other: Blood test
6ml blood sample taken

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cluster of Differentiation 4 (CD4+) T cell subpopulations
Time Frame: Day 0
immunosenescence; number/mm3
Day 0
Cluster of Differentiation 8 (CD8+) T cell subpopulations
Time Frame: Day 0
immunosenescence; number/mm3
Day 0
B cell subpopulations
Time Frame: Day 0
flow cytometry
Day 0
Natural killer (NK) cell subpopulations
Time Frame: Day 0
immunosenescence; number/mm3
Day 0
sCD14 level
Time Frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Day 0
16 ribosomal ribonucleic acid (rRNA) levels
Time Frame: Day 0
polymerase chain reaction (PCR); copies/µl
Day 0
lipopolysaccharide (LPS)-binding protein level
Time Frame: Day 0
ELISA; µg/mL
Day 0
Intestinal Fatty Acid Binding Protein level
Time Frame: Day 0
ELISA; pg/mL
Day 0
Total cholesterol
Time Frame: Day 0
mM/L
Day 0
High Density Lipoprotein
Time Frame: Day 0
mM/L
Day 0
Low Density Lipoprotein
Time Frame: Day 0
mM/L
Day 0
fasting glycemia
Time Frame: Day 0
Day 0
fasting insulinemia
Time Frame: Day 0
mIU/L
Day 0
γ-glutamyl transpeptidase level
Time Frame: Day 0
Day 0
glutamic pyruvic transaminase
Time Frame: Day 0
Day 0
hip circumference
Time Frame: Day 0
cm
Day 0
waist circumference
Time Frame: Day 0
cm
Day 0
minimal arterial tension
Time Frame: Day 0
mmHg
Day 0
maximal arterial tension
Time Frame: Day 0
mmHg
Day 0
Cluster of Differentiation 163 (CD163) level
Time Frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Day 0
soluble tumor necrosis factor-alpha receptor I (sTNFRI) level
Time Frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Day 0
soluble endothelial protein C Receptro (sEPCR) level
Time Frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Day 0
tissue plasminogen activator (tPa) level
Time Frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of insulin and metabolic syndrome
Time Frame: Day 0
% subjects
Day 0
Link between immune activation profile and other features of metabolic syndrome
Time Frame: Day 0
logistic regression of individual markers
Day 0
Immune activation linked to the profile
Time Frame: Day 0
logistic regression
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2016-02/PC-01
  • 2017-A01504-49 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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