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

Completed

• Conditions: Insulin Resistance; Metabolic Syndrome X
• Interventions: Other: Blood test

• Registration Number: NCT03309761
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-16
• Study Start: 2017-12-11
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients aged 55-60	Blood test	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHU Nimes; 🇫🇷 Nîmes, France

Centre d'examen de santé de la Sécurité Sociale de Nîmes; 🇫🇷 Nîmes, France