Clinical trial NCT03309761: Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
Official title: Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Metabolic Syndrome X
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 158
Sex: ALL
Minimum age (years): 55
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers aged between 55-69

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cluster of Differentiation 4 (CD4+) T cell subpopulations
timeFrame: Day 0
measure: Cluster of Differentiation 8 (CD8+) T cell subpopulations
timeFrame: Day 0
measure: B cell subpopulations
timeFrame: Day 0
measure: Natural killer (NK) cell subpopulations
timeFrame: Day 0
measure: sCD14 level
timeFrame: Day 0
measure: 16 ribosomal ribonucleic acid (rRNA) levels
timeFrame: Day 0
measure: lipopolysaccharide (LPS)-binding protein level
timeFrame: Day 0
measure: Intestinal Fatty Acid Binding Protein level
timeFrame: Day 0
measure: Total cholesterol
timeFrame: Day 0
measure: High Density Lipoprotein
timeFrame: Day 0
measure: Low Density Lipoprotein
timeFrame: Day 0
measure: fasting glycemia
timeFrame: Day 0
measure: fasting insulinemia
timeFrame: Day 0
measure: γ-glutamyl transpeptidase level
timeFrame: Day 0
measure: glutamic pyruvic transaminase
timeFrame: Day 0
measure: hip circumference
timeFrame: Day 0
measure: waist circumference
timeFrame: Day 0
measure: minimal arterial tension
timeFrame: Day 0
measure: maximal arterial tension
timeFrame: Day 0
measure: Cluster of Differentiation 163 (CD163) level
timeFrame: Day 0
measure: soluble tumor necrosis factor-alpha receptor I (sTNFRI) level
timeFrame: Day 0
measure: soluble endothelial protein C Receptro (sEPCR) level
timeFrame: Day 0
measure: tissue plasminogen activator (tPa) level
timeFrame: Day 0
Secondary outcomes:
measure: Prevalence of insulin and metabolic syndrome
timeFrame: Day 0
measure: Link between immune activation profile and other features of metabolic syndrome
timeFrame: Day 0
measure: Immune activation linked to the profile
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
city: Nîmes
country: France
facility: Centre d'examen de santé de la Sécurité Sociale de Nîmes
Study officials:
References: