NCT03309761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

November 21, 2025

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

October 5, 2017

Last Update Submit

November 18, 2025

Conditions

Insulin ResistanceMetabolic Syndrome X

Outcome Measures

Primary Outcomes (23)

  • 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 Outcomes (3)

  • Prevalence of insulin and metabolic syndrome

    Day 0

  • Link between immune activation profile and other features of metabolic syndrome

    Day 0

  • Immune activation linked to the profile

    Day 0

Study Arms (1)

Patients aged 55-60

Other: Blood test

Interventions

Blood testOTHER

6ml blood sample taken

Patients aged 55-60

Eligibility Criteria

Age55 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers aged between 55-69

You may qualify if:

  • 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

You may not qualify if:

  • 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 under safeguard of justice or state guardianship
  • The subject refuses to sign the consent
  • The subject does not understand the information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Nimes

Nîmes, 30029, France

Location

Centre d'examen de santé de la Sécurité Sociale de Nîmes

Nîmes, France

Location

Related Publications (1)

  • 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.

    PMID: 33257766RESULT

MeSH Terms

Conditions

Insulin ResistanceMetabolic Syndrome

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 16, 2017

Study Start

December 11, 2017

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

November 21, 2025

Record last verified: 2019-09

Locations

FR(2)