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

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ClinicalTrials.gov Identifier: NCT03309761
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Insulin Resistance Metabolic Syndrome X Other: Blood test

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cluster of Differentiation 4 (CD4+) T cell subpopulations [ Time Frame: Day 0 ]
    immunosenescence; number/mm3

  2. Cluster of Differentiation 8 (CD8+) T cell subpopulations [ Time Frame: Day 0 ]
    immunosenescence; number/mm3

  3. B cell subpopulations [ Time Frame: Day 0 ]
    flow cytometry

  4. Natural killer (NK) cell subpopulations [ Time Frame: Day 0 ]
    immunosenescence; number/mm3

  5. sCD14 level [ Time Frame: Day 0 ]
    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  6. 16 ribosomal ribonucleic acid (rRNA) levels [ Time Frame: Day 0 ]
    polymerase chain reaction (PCR); copies/µl

  7. lipopolysaccharide (LPS)-binding protein level [ Time Frame: Day 0 ]
    ELISA; µg/mL

  8. Intestinal Fatty Acid Binding Protein level [ Time Frame: Day 0 ]
    ELISA; pg/mL

  9. Total cholesterol [ Time Frame: Day 0 ]
    mM/L

  10. High Density Lipoprotein [ Time Frame: Day 0 ]
    mM/L

  11. Low Density Lipoprotein [ Time Frame: Day 0 ]
    mM/L

  12. fasting glycemia [ Time Frame: Day 0 ]
  13. fasting insulinemia [ Time Frame: Day 0 ]
    mIU/L

  14. γ-glutamyl transpeptidase level [ Time Frame: Day 0 ]
  15. glutamic pyruvic transaminase [ Time Frame: Day 0 ]
  16. hip circumference [ Time Frame: Day 0 ]
    cm

  17. waist circumference [ Time Frame: Day 0 ]
    cm

  18. minimal arterial tension [ Time Frame: Day 0 ]
    mmHg

  19. maximal arterial tension [ Time Frame: Day 0 ]
    mmHg

  20. Cluster of Differentiation 163 (CD163) level [ Time Frame: Day 0 ]
    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  21. soluble tumor necrosis factor-alpha receptor I (sTNFRI) level [ Time Frame: Day 0 ]
    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  22. soluble endothelial protein C Receptro (sEPCR) level [ Time Frame: Day 0 ]
    ng/ml, enzyme-linked immunosorbent assays (ELISA)

  23. tissue plasminogen activator (tPa) level [ Time Frame: Day 0 ]
    ng/ml, enzyme-linked immunosorbent assays (ELISA)


Secondary Outcome Measures :
  1. Prevalence of insulin and metabolic syndrome [ Time Frame: Day 0 ]
    % subjects

  2. Link between immune activation profile and other features of metabolic syndrome [ Time Frame: Day 0 ]
    logistic regression of individual markers

  3. Immune activation linked to the profile [ Time Frame: Day 0 ]
    logistic regression



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Ages Eligible for Study:   55 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers aged between 55-69
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309761


Contacts
Contact: Pierre Corbeau +33 (0)4 66 68 31 49 pierre.corbeau@igh.cnrs.fr

Locations
France
CHU Nimes Not yet recruiting
Nîmes, France, 30029
Contact: Anissa Megzari       drc@chu-nimes.fr   
Principal Investigator: Pierre Corbeau, MD         
Sub-Investigator: Jean-Philippe Lavigne, MD         
Sub-Investigator: Robert Sabatier, MD         
Centre d'examen de santé de la Sécurité Sociale de Nîmes Recruiting
Nîmes, France
Contact: Elisabeth Maggia    04 30 67 94 70    elisabeth.maggia@cpam-nimes.cnamts.fr   
Principal Investigator: Elisabeth Maggia         
Sub-Investigator: Patricia Le Merre         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03309761     History of Changes
Other Study ID Numbers: NIMAO/2016-02/PC-01
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases