Insulin ResistanceMETACTIVNCT03309761
Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
An observational study of Insulin Resistance and Metabolic Syndrome X, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 55 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Metabolic Syndrome X
- What is being tested?
- Blood test
- How many people
- 158 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Dec 2017to 20 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers aged between 55-69
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Nimes
Nîmes, 30029
Centre d'examen de santé de la Sécurité Sociale de Nîmes
Nîmes
About this study
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.
- Conditions
- Insulin Resistance, Metabolic Syndrome X
- Being tested
- Blood test
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
6ml blood sample taken
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 55-60 | Not described Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cluster of Differentiation 4 (CD4+) T cell subpopulations
immunosenescence; number/mm3
Measured: Day 0
Cluster of Differentiation 8 (CD8+) T cell subpopulations
immunosenescence; number/mm3
Measured: Day 0
B cell subpopulations
flow cytometry
Measured: Day 0
Natural killer (NK) cell subpopulations
immunosenescence; number/mm3
Measured: Day 0
sCD14 level
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Measured: Day 0
16 ribosomal ribonucleic acid (rRNA) levels
polymerase chain reaction (PCR); copies/µl
Measured: Day 0
lipopolysaccharide (LPS)-binding protein level
ELISA; µg/mL
Measured: Day 0
Intestinal Fatty Acid Binding Protein level
ELISA; pg/mL
Measured: Day 0
Total cholesterol
mM/L
Measured: Day 0
High Density Lipoprotein
mM/L
Measured: Day 0
Low Density Lipoprotein
mM/L
Measured: Day 0
fasting glycemia
Measured: Day 0
fasting insulinemia
mIU/L
Measured: Day 0
γ-glutamyl transpeptidase level
Measured: Day 0
glutamic pyruvic transaminase
Measured: Day 0
hip circumference
cm
Measured: Day 0
waist circumference
cm
Measured: Day 0
minimal arterial tension
mmHg
Measured: Day 0
maximal arterial tension
mmHg
Measured: Day 0
Cluster of Differentiation 163 (CD163) level
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Measured: Day 0
soluble tumor necrosis factor-alpha receptor I (sTNFRI) level
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Measured: Day 0
soluble endothelial protein C Receptro (sEPCR) level
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Measured: Day 0
tissue plasminogen activator (tPa) level
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Measured: Day 0
Secondary outcomes (3)
Prevalence of insulin and metabolic syndrome
% subjects
Measured: Day 0
Link between immune activation profile and other features of metabolic syndrome
logistic regression of individual markers
Measured: Day 0
Immune activation linked to the profile
logistic regression
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start11 Dec 2017
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309761
- Sponsor's protocol ID
- NIMAO/2016-02/PC-01
- Other IDs
- 2017-A01504-49
- Acronym
- METACTIV
- Status last verified
- Sep 2019
- First submitted
- 5 Oct 2017
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33257766
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
- ClinicalTrials.gov ID
- NCT03309761
- Acronym / sponsor ID
- METACTIV / NIMAO/2016-02/PC-01
- Conditions
- Insulin Resistance, Metabolic Syndrome X
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 55-60 | – | Other: Blood test |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers aged between 55-69
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test6ml blood sample taken | Other | Patients aged 55-60 |
Primary outcome
Cluster of Differentiation 4 (CD4+) T cell subpopulations
Time frame: Day 0
immunosenescence; number/mm3
Cluster of Differentiation 8 (CD8+) T cell subpopulations
Time frame: Day 0
immunosenescence; number/mm3
B cell subpopulations
Time frame: Day 0
flow cytometry
Natural killer (NK) cell subpopulations
Time frame: Day 0
immunosenescence; number/mm3
sCD14 level
Time frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
16 ribosomal ribonucleic acid (rRNA) levels
Time frame: Day 0
polymerase chain reaction (PCR); copies/µl
lipopolysaccharide (LPS)-binding protein level
Time frame: Day 0
ELISA; µg/mL
Intestinal Fatty Acid Binding Protein level
Time frame: Day 0
ELISA; pg/mL
Total cholesterol
Time frame: Day 0
mM/L
High Density Lipoprotein
Time frame: Day 0
mM/L
Low Density Lipoprotein
Time frame: Day 0
mM/L
fasting glycemia
Time frame: Day 0
fasting insulinemia
Time frame: Day 0
mIU/L
γ-glutamyl transpeptidase level
Time frame: Day 0
glutamic pyruvic transaminase
Time frame: Day 0
hip circumference
Time frame: Day 0
cm
waist circumference
Time frame: Day 0
cm
minimal arterial tension
Time frame: Day 0
mmHg
maximal arterial tension
Time frame: Day 0
mmHg
Cluster of Differentiation 163 (CD163) level
Time frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
soluble tumor necrosis factor-alpha receptor I (sTNFRI) level
Time frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
soluble endothelial protein C Receptro (sEPCR) level
Time frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
tissue plasminogen activator (tPa) level
Time frame: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
3 secondary outcomes
Prevalence of insulin and metabolic syndrome
Time frame: Day 0
Link between immune activation profile and other features of metabolic syndrome
Time frame: Day 0
Immune activation linked to the profile
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 33257766Cezar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Metabolic Syndrome X, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cluster of Differentiation 4 (CD4+) T cell subpopulations (time frame: Day 0). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.