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

Insulin Resistance Clinical Trial

— METACTIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309761
• Other study ID #: NIMAO/2016-02/PC-01
• Status: Completed
• Start date: December 11, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: September 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• Blood test
6ml blood sample taken

Locations

Country	Name	City	State
France	Centre d'examen de santé de la Sécurité Sociale de Nîmes	Nîmes
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cluster of Differentiation 4 (CD4+) T cell subpopulations	immunosenescence; number/mm3	Day 0
Primary	Cluster of Differentiation 8 (CD8+) T cell subpopulations	immunosenescence; number/mm3	Day 0
Primary	B cell subpopulations	flow cytometry	Day 0
Primary	Natural killer (NK) cell subpopulations	immunosenescence; number/mm3	Day 0
Primary	sCD14 level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
Primary	16 ribosomal ribonucleic acid (rRNA) levels	polymerase chain reaction (PCR); copies/µl	Day 0
Primary	lipopolysaccharide (LPS)-binding protein level	ELISA; µg/mL	Day 0
Primary	Intestinal Fatty Acid Binding Protein level	ELISA; pg/mL	Day 0
Primary	Total cholesterol	mM/L	Day 0
Primary	High Density Lipoprotein	mM/L	Day 0
Primary	Low Density Lipoprotein	mM/L	Day 0
Primary	fasting glycemia		Day 0
Primary	fasting insulinemia	mIU/L	Day 0
Primary	?-glutamyl transpeptidase level		Day 0
Primary	glutamic pyruvic transaminase		Day 0
Primary	hip circumference	cm	Day 0
Primary	waist circumference	cm	Day 0
Primary	minimal arterial tension	mmHg	Day 0
Primary	maximal arterial tension	mmHg	Day 0
Primary	Cluster of Differentiation 163 (CD163) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
Primary	soluble tumor necrosis factor-alpha receptor I (sTNFRI) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
Primary	soluble endothelial protein C Receptro (sEPCR) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
Primary	tissue plasminogen activator (tPa) level	ng/ml, enzyme-linked immunosorbent assays (ELISA)	Day 0
Secondary	Prevalence of insulin and metabolic syndrome	% subjects	Day 0
Secondary	Link between immune activation profile and other features of metabolic syndrome	logistic regression of individual markers	Day 0
Secondary	Immune activation linked to the profile	logistic regression	Day 0