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

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: Completed
• Conditions: Insulin Resistance; Metabolic Syndrome X
• Intervention / Treatment: Other: Blood test

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients aged 55-60	Other: Blood test; 6ml blood sample taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cluster of Differentiation 4 (CD4+) T cell subpopulations	immunosenescence; number/mm3	Day 0
Cluster of Differentiation 8 (CD8+) T cell subpopulations	immunosenescence; number/mm3	Day 0
B cell subpopulations	flow cytometry	Day 0
Natural killer (NK) cell subpopulations	immunosenescence; number/mm3	Day 0
sCD14 level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
16 ribosomal ribonucleic acid (rRNA) levels	polymerase chain reaction (PCR); copies/µl	Day 0
lipopolysaccharide (LPS)-binding protein level	ELISA; µg/mL	Day 0
Intestinal Fatty Acid Binding Protein level	ELISA; pg/mL	Day 0
Total cholesterol	mM/L	Day 0
High Density Lipoprotein	mM/L	Day 0
Low Density Lipoprotein	mM/L	Day 0
fasting glycemia		Day 0
fasting insulinemia	mIU/L	Day 0
γ-glutamyl transpeptidase level		Day 0
glutamic pyruvic transaminase		Day 0
hip circumference	cm	Day 0
waist circumference	cm	Day 0
minimal arterial tension	mmHg	Day 0
maximal arterial tension	mmHg	Day 0
Cluster of Differentiation 163 (CD163) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
soluble tumor necrosis factor-alpha receptor I (sTNFRI) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
soluble endothelial protein C Receptro (sEPCR) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
tissue plasminogen activator (tPa) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of insulin and metabolic syndrome	% subjects	Day 0
Link between immune activation profile and other features of metabolic syndrome	logistic regression of individual markers	Day 0
Immune activation linked to the profile	logistic regression	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Cezar R, Winter A, Desigaud D, Pastore M, Kundura L, Dupuy AM, Cognot C, Vincent T, Reynes C, Dunyach-Remy C, Lavigne JP, Sabatier R, Le Merre P, Maggia E, Corbeau P. Identification of distinct immune activation profiles in adult humans. Sci Rep. 2020 Nov 30;10(1):20824. doi: 10.1038/s41598-020-77707-6.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): August 20, 2018
• Study Completion (Actual): August 20, 2018

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Estimated): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome; Insulin Resistance; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID 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